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William C Stewart - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of changing to the Travoprost timolol maleate fixed combination duotrav from prior mono or adjunctive therapy
Clinical Ophthalmology, 2010Co-Authors: Norbert Pfeiffer, Jeanette A. Stewart, Hubert Maier, Marialuise Scherzer, Mark C Jasek, Sonja Schoelzel, William C StewartAbstract:Purpose: To assess the safety and efficacy of changing to the Travoprost/timolol fixed combination (TTFC) from other mono- or adjunctive therapies.
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twenty four hour intraocular pressure control with the Travoprost timolol maleate fixed combination compared with Travoprost when both are dosed in the evening in primary open angle glaucoma
British Journal of Ophthalmology, 2009Co-Authors: Anastasios G P Konstas, Dimitrios G Mikropoulos, Annabettina Haidich, Kostantinos S Ntampos, William C StewartAbstract:Objective: To evaluate the 24 h efficacy and safety of the Travoprost/timolol maleate fixed combination (TTFC) versus Travoprost when both are dosed in the evening in primary open-angle glaucoma patients. Methods: Prospective, double-masked, crossover, active-controlled, randomised 24 h comparison. After a 6 week medicine-free period, patients were randomised to either TTFC or Travoprost for 8 weeks and were then switched to the opposite treatment for another 8 weeks. At the end of the washout and treatment periods, a 24 h pressure curve was performed. Results: Thirty-two patients completed the study. The TTFC group demonstrated a lower absolute intraocular pressure level (2.4 mm Hg) for the 24 h curve and at all time points, compared with Travoprost (p⩽0.047). The pressure reduction from untreated baseline was significantly different between treatments for all time points (p = 0.018). The mean 24 h pressure fluctuation was lower with TTFC (3.0 mm Hg) compared with Travoprost (4.0 mm Hg, p = 0.001). No statistical difference existed between the two treatment groups for any adverse event (p>0.05). Conclusions: This study suggests that when both drugs are dosed in the evening the TTFC provides improved intraocular pressure reduction, compared with Travoprost, over the 24 h curve and for each individual time point in primary open-angle glaucoma patients.
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efficacy safety and improved tolerability of Travoprost bak free ophthalmic solution compared with prior prostaglandin therapy
Clinical Ophthalmology, 2008Co-Authors: Charles J Henry, Jeanette A. Stewart, James H Peace, William C StewartAbstract:Purpose To evaluate the efficacy, safety and tolerability of changing to Travoprost BAK-free from prior prostaglandin therapy in patients with primary open-angle glaucoma or ocular hypertension.
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efficacy and safety of latanoprost versus Travoprost in exfoliative glaucoma patients
Ophthalmology, 2007Co-Authors: Anastasios G P Konstas, Vassilios P Kozobolis, Ioannis E Katsimpris, Kostantinos G Boboridis, Stavrenia Koukoula, Jessica N Jenkins, William C StewartAbstract:Objective To evaluate 24-hour intraocular pressure (IOP) efficacy of latanoprost versus Travoprost, each given every evening, in exfoliative glaucoma patients. Design Prospective, observer-masked, crossover comparison. Participants Forty patients with exfoliation glaucoma. Methods Patients with a pressure of >24 mmHg were randomized to latanoprost or Travoprost for an 8-week treatment period after a 6-week medicine-free period. Patients were then switched to the opposite treatment for the second period. At untreated baseline and at the end of each treatment period the IOP was measured at 6 am, 10 am, 2 pm, 6 pm, 10 pm, and 2 am. Main Outcome Measure Diurnal IOP. Results The mean 24-hour IOP was 25.1±2.5 mmHg at baseline, 17.8±2.1 mmHg on latanoprost, and 17.3±2.2 mmHg on Travoprost ( P = 0.001). Individual time points were similar between treatments, except at 6 pm when Travoprost provided lower IOP (16.7±2.6 vs 17.9±2.5 mmHg, P P = 0.03). Conclusions Latanoprost and Travoprost both significantly reduce the 24-hour IOP from baseline in exfoliative glaucoma, but Travoprost may demonstrate a greater hypotensive efficacy in the late afternoon.
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the efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to Travoprost in patients with ocular hypertension or primary open angle glaucoma
European Journal of Ophthalmology, 2006Co-Authors: Gabor Hollo, D Chiselita, N Petkova, Barbara Cvenkel, I Liehneova, B Izgi, Andras Berta, Jerzy Szaflik, E Turacli, William C StewartAbstract:PURPOSE To compare the efficacy and safety of timolol maleate 0.5% versus brinzolamide 1% when added to Travoprost 0.004% in patients with ocular hypertension or primary open-angle glaucoma. DESIGN A prospective, double-masked, randomized, active-controlled, parallel comparison. METHODS Qualified patients at Visit 1 were placed on Travoprost dosed every evening for 4 weeks and then were randomized at baseline (Visit 2) to the addition of timolol maleate or brinzolamide each given twice daily. Patients returned to clinic at Week 4 (Visit 3) for a safety visit and Week 12 (Visit 4) for an efficacy visit. At Visits 2 and 4 the intraocular pressure (IOP) was measured at 08:00, 12:00, and 16:00 hours. RESULTS Ninety-seven patients on brinzolamide had a baseline diurnal IOP of 21.5+/-2.2 mmHg and 95 on timolol maleate had 21.3+/-2.5 mmHg, each added to Travoprost. The diurnal mean IOP at Week 12 was 18.1+/-2.7 mmHg for brinzolamide and 18.1+/-3.0 mmHg for timolol maleate (p=0.96). There was no statistical difference found between treatment groups in the absolute level of pressure, or in the reduction in IOP from baseline, at each time point or for the diurnal curve (p>0.05). There was no significant difference for any adverse event between groups (p>0.05), with the most common side effect being conjunctival hyperemia in 15/97 (16%) brinzolamide and 6/95 (6%) timolol treated patients (p=0.06). CONCLUSIONS This study showed that brinzolamide provides similar safety and efficacy compared to timolol maleate when added to Travoprost.
Theresa A Landry - One of the best experts on this subject based on the ideXlab platform.
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a 3 month safety and efficacy study of Travoprost 0 004 ophthalmic solution compared with timolol in pediatric patients with glaucoma or ocular hypertension
Journal of Aapos, 2017Co-Authors: El Roy Dixon, Theresa A Landry, Subha Venkataraman, Nancy Gustafson, Craig Salem, Yasmin S Bradfield, Leyla Ali Aljasim, Robert M FeldmanAbstract:Purpose To evaluate efficacy and safety of Travoprost in pediatric patients with ocular hypertension or glaucoma and demonstrate its noninferiority to timolol. Methods Patients aged 2 months to Results Of 157 patients included (mean age, 9.6 years), 77 received Travoprost and 75 timolol. All patients experienced a significant reduction in IOP in the study eye at 3 months: the mean IOP change from baseline was −5.4 mm Hg for Travoprost; −5.3 mm Hg, for timolol. The mean difference between Travoprost and timolol at month 3 was −0.1 mm Hg (95% CI, −1.5 to 1.4 mm Hg). The most common treatment-related adverse events for the Travoprost group were ocular hyperemia and eyelash growth. No serious adverse events were reported. Conclusions This study found Travoprost to be noninferior to timolol in lowering IOP in patients with pediatric glaucoma or ocular hypertension. Travoprost was well-tolerated, and no treatment-related systemic adverse events were reported.
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Travoprost 0 004 with and without benzalkonium chloride a comparison of safety and efficacy
Journal of Glaucoma, 2007Co-Authors: Richard A Lewis, Theresa A Landry, Kenneth E Sullivan, Jaime E Dickerson, Gregory J Katz, David T Wells, Mark J Weiss, John E James, Dawnelle B Montgomery, And Michael V W BergaminiAbstract:PURPOSE: To compare the safety and efficacy of Travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of Travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. METHODS: The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either Travoprost 0.004% with BAC (n=346), or Travoprost 0.004% without BAC (n=344) dosed once-daily each evening. Patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM, and 4 PM were taken at study visits on week 2, week 6, and month 3. RESULTS: Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for Travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg for Travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were within +/-0.8 mm Hg at 9 of 9 study visits and times in both the per protocol and intent-to-treat data sets. Adverse events and the number of patients discontinued owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with Travoprost 0.004% without BAC and Travoprost 0.004% with BAC, respectively. CONCLUSION: Travoprost 0.004% without BAC is equivalent to Travoprost 0.004% with BAC in both safety and efficacy.
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patients and physicians perceptions of the Travoprost dosing aid an open label multicenter study of adherence with prostaglandin analogue therapy for open angle glaucoma or ocular hypertension
Clinical Therapeutics, 2006Co-Authors: Brian Flowers, Theresa A Landry, Michael V W Bergamini, Martin Wand, Jody R Piltzseymour, Stanley J Berke, Douglas Day, James Teague, Tonya M Smoot, Sushanta MallickAbstract:Abstract Objective: This study describes patients' and physicians' perceptions of issues related to dosing adherence with topical therapies for lowering intraocular pressure before and after use of the Travoprost dosing aid (Travatan™ Dosing Aid, Alcon Research Ltd., Fort Worth, Texas). Methods: The study had an open-label, multicenter, single-treatment-arm design that included sequential patients with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension who were taking any prostaglandin analogue monotherapy. Ten participating physicians were chosen on the basis of factors such as their experience, qualifications, and previous clinical study participation. The study consisted of 2 visits: screening and week 4. Patients were asked to complete a survey about their medication adherence before study entry at the screening visit and at study exit during the week-4 visit. In addition, each physician was asked to complete an entry and exit survey on each patient as well as a survey to provide feedback on the Travoprost dosing aid. Results: Of the 87 enrolled patients, 6 did not complete the exit survey; therefore, 81 patients were included in the intent-to-treat analysis. Mean (SD) age at enrollment was 65.4 (11.6) years; 61.7% (50/81) of the patients were women and 60.5% (49/81) were white. Most patients (96.3% [78/81]) had open-angle glaucoma. Participating physicians perceived that problems involving dosing and adherence were reduced after patients used the dosing aid. Physicians indicated that they would recommend continued use of the Travoprost dosing aid for 91.3% (73/80) of patients. All 10 participating physicians said that they would recommend the dosing aid to patients in the future. Of the 81 patients, the majority (68.8% [55/80]) indicated that they would like to continue using the Travoprost dosing aid. For 67.5% (54/80) of patients, dosing adherence as recorded by the Travoprost dosing aid was >70%. The dosing lever (39.7% [31/78]) and the visual alarm (29.5% [23/78]) were the 2 most favored features of the dosing aid reported by all evaluable patients. The majority of patients (58.8% [47/80]) indicated that they were “relieved” or “very relieved” that the doctor was able to monitor when they dosed their medication; few (7.5% [6/80]) were “concerned” or “very concerned” that the doctor was able to monitor their dosing. Conclusions: The Travoprost dosing aid was perceived to be effective in reminding this group of patients to take their medication as prescribed. In this study, the device was well accepted by both patients and physicians.
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a three month multicenter double masked study of the safety and efficacy of Travoprost 0 004 timolol 0 5 ophthalmic solution compared to Travoprost 0 004 ophthalmic solution and timolol 0 5 dosed concomitantly in subjects with open angle glaucoma or
Journal of Glaucoma, 2005Co-Authors: Bret A Hughes, Theresa A Landry, Sushanta Mallick, Randy E Craven, Jason Bacharach, Martin Kaback, Michael V W BergaminiAbstract:Purpose:The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of Travoprost 0.004% (TRAVATAN®) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertens
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efficacy and safety of a fixed combination of Travoprost 0 004 timolol 0 5 ophthalmic solution once daily for open angle glaucoma or ocular hypertension
American Journal of Ophthalmology, 2005Co-Authors: Joel S Schuman, Theresa A Landry, Kenneth E Sullivan, Sushanta Mallick, Michael V W Bergamini, Gregory J Katz, Richard A Lewis, Charles J Henry, David T Wells, Stella M RobertsonAbstract:Purpose To compare the efficacy of a fixed combination of Travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus Travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months. Design Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial. Methods Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer. Results Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination Travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant Travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of Travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with Travoprost/timolol combination and concomitant Travoprost + timolol, respectively. Conclusions Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant Travoprost + timolol. This study demonstrates that the fixed combination of Travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.
Michael V W Bergamini - One of the best experts on this subject based on the ideXlab platform.
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patients and physicians perceptions of the Travoprost dosing aid an open label multicenter study of adherence with prostaglandin analogue therapy for open angle glaucoma or ocular hypertension
Clinical Therapeutics, 2006Co-Authors: Brian Flowers, Theresa A Landry, Michael V W Bergamini, Martin Wand, Jody R Piltzseymour, Stanley J Berke, Douglas Day, James Teague, Tonya M Smoot, Sushanta MallickAbstract:Abstract Objective: This study describes patients' and physicians' perceptions of issues related to dosing adherence with topical therapies for lowering intraocular pressure before and after use of the Travoprost dosing aid (Travatan™ Dosing Aid, Alcon Research Ltd., Fort Worth, Texas). Methods: The study had an open-label, multicenter, single-treatment-arm design that included sequential patients with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension who were taking any prostaglandin analogue monotherapy. Ten participating physicians were chosen on the basis of factors such as their experience, qualifications, and previous clinical study participation. The study consisted of 2 visits: screening and week 4. Patients were asked to complete a survey about their medication adherence before study entry at the screening visit and at study exit during the week-4 visit. In addition, each physician was asked to complete an entry and exit survey on each patient as well as a survey to provide feedback on the Travoprost dosing aid. Results: Of the 87 enrolled patients, 6 did not complete the exit survey; therefore, 81 patients were included in the intent-to-treat analysis. Mean (SD) age at enrollment was 65.4 (11.6) years; 61.7% (50/81) of the patients were women and 60.5% (49/81) were white. Most patients (96.3% [78/81]) had open-angle glaucoma. Participating physicians perceived that problems involving dosing and adherence were reduced after patients used the dosing aid. Physicians indicated that they would recommend continued use of the Travoprost dosing aid for 91.3% (73/80) of patients. All 10 participating physicians said that they would recommend the dosing aid to patients in the future. Of the 81 patients, the majority (68.8% [55/80]) indicated that they would like to continue using the Travoprost dosing aid. For 67.5% (54/80) of patients, dosing adherence as recorded by the Travoprost dosing aid was >70%. The dosing lever (39.7% [31/78]) and the visual alarm (29.5% [23/78]) were the 2 most favored features of the dosing aid reported by all evaluable patients. The majority of patients (58.8% [47/80]) indicated that they were “relieved” or “very relieved” that the doctor was able to monitor when they dosed their medication; few (7.5% [6/80]) were “concerned” or “very concerned” that the doctor was able to monitor their dosing. Conclusions: The Travoprost dosing aid was perceived to be effective in reminding this group of patients to take their medication as prescribed. In this study, the device was well accepted by both patients and physicians.
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a three month multicenter double masked study of the safety and efficacy of Travoprost 0 004 timolol 0 5 ophthalmic solution compared to Travoprost 0 004 ophthalmic solution and timolol 0 5 dosed concomitantly in subjects with open angle glaucoma or
Journal of Glaucoma, 2005Co-Authors: Bret A Hughes, Theresa A Landry, Sushanta Mallick, Randy E Craven, Jason Bacharach, Martin Kaback, Michael V W BergaminiAbstract:Purpose:The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of Travoprost 0.004% (TRAVATAN®) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertens
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efficacy and safety of a fixed combination of Travoprost 0 004 timolol 0 5 ophthalmic solution once daily for open angle glaucoma or ocular hypertension
American Journal of Ophthalmology, 2005Co-Authors: Joel S Schuman, Theresa A Landry, Kenneth E Sullivan, Sushanta Mallick, Michael V W Bergamini, Gregory J Katz, Richard A Lewis, Charles J Henry, David T Wells, Stella M RobertsonAbstract:Purpose To compare the efficacy of a fixed combination of Travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus Travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months. Design Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial. Methods Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer. Results Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination Travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant Travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of Travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with Travoprost/timolol combination and concomitant Travoprost + timolol, respectively. Conclusions Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant Travoprost + timolol. This study demonstrates that the fixed combination of Travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.
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comparison of the diurnal ocular hypotensive efficacy of Travoprost and latanoprost over a 44 hour period in patients with elevated intraocular pressure
Clinical Therapeutics, 2004Co-Authors: Harvey Dubiner, Theresa A Landry, Russell M Andrew, Lewis H Silver, Alan L Weiner, Michael V W Bergamini, Stella M Robertson, Darell F Turner, Marla D Sircy, Johan PrzydrygaAbstract:Abstract Background: Prostaglandin analogues are effective ocular hypotensive agents and are being used increasingly in the treatment of elevated intraocular pressure (IOP). These agents are typically dosed once daily. Objectives: A pilot study was conducted to evaluate the duration of Travoprost's IOP-lowering efficacy up to 84 hours after the final dose in patients with open-angle glaucoma. A follow-up study was conducted to compare diurnal IOP control with Travoprost and latanoprost over a 44-hour period. Methods: In the open label pilot study, patients received 0.004% Travoprost in both eyes at 8 pm daily for 2 weeks. After 2 weeks, IOP was measured before administration of the last daily dose, every 4 hours thereafter for 36 hours, and 60 and 84 hours after the last dose, with no additional ocular hypotensive medication given. In the controlled, double-masked, parallel-group, follow-up study, patients were randomized to self-administer 1 drop of the marketed doses of 0.004% Travoprost or 0.005% latanoprost in both eyes at 8 pm daily for 2 weeks. At the end of this period, patients returned to the facility at ∼8 pm for IOP measurement and administration of the final dose of study medication. IOP was then measured at 4-hour intervals for 44 hours after the last dose, with no additional ocular hypotensive medication given. Results: The pilot study included 21 patients (67% female, 33% male; age range, 35–81 years) with open-angle glaucoma. IOP values were significantly below baseline at all time points up to 84 hours after the final dose of Travoprost ( P P = 0.006). Travoprost lowered IOP significantly at all time points throughout the 44-hour period after the last dose (mean IOP, ≤18 mm Hg; P P = 0.041) and 24 hours after the last dose ( P = 0.006). Latanoprost showed greater IOP-lowering efficacy compared with Travoprost 4 hours after the last dose ( P = 0.040). IOP reductions were significantly different from zero at all time points with both treatments ( P ≤ 0.001). Conclusions: The results of the pilot study suggest that Travoprost produces reductions in IOP that may be sustained for up to 84 hours after dosing. The results of the follow-up study suggest that both prostaglandin analogues significantly lower IOP from baseline in patients with open-angle glaucoma and provide excellent diurnal IOP control throughout a 24-hour period.
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response to Travoprost in black and nonblack patients with open angle glaucoma or ocular hypertension
Advances in Therapy, 2003Co-Authors: Peter A Netland, Kenneth E Sullivan, Lewis H Silver, Alan L Weiner, Michael V W Bergamini, Stella M Robertson, Alberta A Davis, Scott Krueger, Travoprost Study GroupsAbstract:Two prospective, controlled, multicenter, double-masked studies—one lasting 6 months (n=594) and the other, 12 months (n=787)—examined the intraocular pressure (IOP)-lowering efficacy of Travoprost in 1381 black and nonblack patients with open-angle glaucoma or ocular hypertension. Investigated regimens were Travoprost 0.004% once daily, latanoprost 0.005% once daily, and timolol 0.5% twice daily. In both studies, mean IOP was significantly lower in blacks treated with Travoprost. The IOP reduction was also significantly greater in blacks after adjustments for age, sex, iris color, diagnosis, and corneal thickness. Timolol lowered mean IOP to a greater extent in nonblack patients. The significantly larger IOP reduction with Travoprost compared with timolol in both racial groups was more pronounced in blacks. Travoprost also was superior to latanoprost in blacks. Mean changes from baseline generally were greater for black than for nonblack patients, although the differences did not achieve statistical significance. The response rate to Travoprost was higher in blacks. The most common adverse effect was hyperemia.
Stella M Robertson - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of a fixed combination of Travoprost 0 004 timolol 0 5 ophthalmic solution once daily for open angle glaucoma or ocular hypertension
American Journal of Ophthalmology, 2005Co-Authors: Joel S Schuman, Theresa A Landry, Kenneth E Sullivan, Sushanta Mallick, Michael V W Bergamini, Gregory J Katz, Richard A Lewis, Charles J Henry, David T Wells, Stella M RobertsonAbstract:Purpose To compare the efficacy of a fixed combination of Travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus Travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months. Design Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial. Methods Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer. Results Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination Travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant Travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of Travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with Travoprost/timolol combination and concomitant Travoprost + timolol, respectively. Conclusions Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant Travoprost + timolol. This study demonstrates that the fixed combination of Travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.
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comparison of the diurnal ocular hypotensive efficacy of Travoprost and latanoprost over a 44 hour period in patients with elevated intraocular pressure
Clinical Therapeutics, 2004Co-Authors: Harvey Dubiner, Theresa A Landry, Russell M Andrew, Lewis H Silver, Alan L Weiner, Michael V W Bergamini, Stella M Robertson, Darell F Turner, Marla D Sircy, Johan PrzydrygaAbstract:Abstract Background: Prostaglandin analogues are effective ocular hypotensive agents and are being used increasingly in the treatment of elevated intraocular pressure (IOP). These agents are typically dosed once daily. Objectives: A pilot study was conducted to evaluate the duration of Travoprost's IOP-lowering efficacy up to 84 hours after the final dose in patients with open-angle glaucoma. A follow-up study was conducted to compare diurnal IOP control with Travoprost and latanoprost over a 44-hour period. Methods: In the open label pilot study, patients received 0.004% Travoprost in both eyes at 8 pm daily for 2 weeks. After 2 weeks, IOP was measured before administration of the last daily dose, every 4 hours thereafter for 36 hours, and 60 and 84 hours after the last dose, with no additional ocular hypotensive medication given. In the controlled, double-masked, parallel-group, follow-up study, patients were randomized to self-administer 1 drop of the marketed doses of 0.004% Travoprost or 0.005% latanoprost in both eyes at 8 pm daily for 2 weeks. At the end of this period, patients returned to the facility at ∼8 pm for IOP measurement and administration of the final dose of study medication. IOP was then measured at 4-hour intervals for 44 hours after the last dose, with no additional ocular hypotensive medication given. Results: The pilot study included 21 patients (67% female, 33% male; age range, 35–81 years) with open-angle glaucoma. IOP values were significantly below baseline at all time points up to 84 hours after the final dose of Travoprost ( P P = 0.006). Travoprost lowered IOP significantly at all time points throughout the 44-hour period after the last dose (mean IOP, ≤18 mm Hg; P P = 0.041) and 24 hours after the last dose ( P = 0.006). Latanoprost showed greater IOP-lowering efficacy compared with Travoprost 4 hours after the last dose ( P = 0.040). IOP reductions were significantly different from zero at all time points with both treatments ( P ≤ 0.001). Conclusions: The results of the pilot study suggest that Travoprost produces reductions in IOP that may be sustained for up to 84 hours after dosing. The results of the follow-up study suggest that both prostaglandin analogues significantly lower IOP from baseline in patients with open-angle glaucoma and provide excellent diurnal IOP control throughout a 24-hour period.
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response to Travoprost in black and nonblack patients with open angle glaucoma or ocular hypertension
Advances in Therapy, 2003Co-Authors: Peter A Netland, Kenneth E Sullivan, Lewis H Silver, Alan L Weiner, Michael V W Bergamini, Stella M Robertson, Alberta A Davis, Scott Krueger, Travoprost Study GroupsAbstract:Two prospective, controlled, multicenter, double-masked studies—one lasting 6 months (n=594) and the other, 12 months (n=787)—examined the intraocular pressure (IOP)-lowering efficacy of Travoprost in 1381 black and nonblack patients with open-angle glaucoma or ocular hypertension. Investigated regimens were Travoprost 0.004% once daily, latanoprost 0.005% once daily, and timolol 0.5% twice daily. In both studies, mean IOP was significantly lower in blacks treated with Travoprost. The IOP reduction was also significantly greater in blacks after adjustments for age, sex, iris color, diagnosis, and corneal thickness. Timolol lowered mean IOP to a greater extent in nonblack patients. The significantly larger IOP reduction with Travoprost compared with timolol in both racial groups was more pronounced in blacks. Travoprost also was superior to latanoprost in blacks. Mean changes from baseline generally were greater for black than for nonblack patients, although the differences did not achieve statistical significance. The response rate to Travoprost was higher in blacks. The most common adverse effect was hyperemia.
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Travoprost compared with latanoprost and timolol in patients with open angle glaucoma or ocular hypertension
American Journal of Ophthalmology, 2001Co-Authors: Theresa A Landry, Kenneth E Sullivan, Russell M Andrew, Lewis H Silver, Alan L Weiner, Sushanta Mallick, Jaime E Dickerson, Michael V W Bergamini, Stella M RobertsonAbstract:● PURPOSE: This study evaluated the safety and intraocular pressure–lowering efficacy of two concentrations of Travoprost (0.0015% and 0.004%) compared with latanoprost 0.005% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. ● METHODS: Eight hundred one patients with open-angle glaucoma or ocular hypertension were randomly assigned to Travoprost 0.0015%, Travoprost 0.004%, latanoprost 0.005%, or timolol 0.5%. The efficacy and safety of Travoprost (0.0015% and 0.004%) daily was compared with latanoprost daily and timolol twice daily for a period of 12 months. ● RESULTS: Travoprost was equal or superior to latanoprost and superior to timolol with mean intraocular pressure over visits and time of day ranging from 17.9 to 19.1 mm Hg (Travoprost 0.0015%), 17.7 to 19.1 mm Hg (Travoprost 0.004%), 18.5 to 19.2 mm Hg (latanoprost), and 19.4 to 20.3 mm Hg (timolol). For all visits pooled, the mean intraocular pressure at 4 PM for Travoprost was 0.7 mm Hg (0.0015%, P .0502) and 0.8 mm Hg (0.004%, P .0191) lower than for latanoprost. Travoprost 0.004% was more effective than latanoprost and timolol in reducing intraocular pressure in black patients by up to 2.4 mm Hg (versus latanoprost) and 4.6 mm Hg (versus timolol). Based on a criterion of 30% or greater intraocular pressure reduction from diurnal baseline or intraocular pressure 17 mm Hg or less, Travoprost 0.0015% and 0.004% had an overall response to treatment of 49.3% and 54.7%, respectively, compared with 49.6% for latanoprost and 39.0% for timolol. Iris pigmentation change was observed in 10 of 201 of patients (5.0%) receiving Travoprost 0.0015%, six of 196 of patients (3.1%) receiving Travoprost 0.004%, 10 of 194 of patients (5.2%) receiving latanoprost, and none of the patients receiving timolol (0 of 196). The average ocular hyperemia score was less than 1 on a scale of 0 to 3, indicating that on average patients experienced between none/trace and mild for all treatment groups. There were no serious, unexpected, related adverse events reported for any therapy. ● CONCLUSIONS: Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor agonist, is equal or superior to latanoprost and superior to timolol in lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In addition, Travoprost 0.004% is significantly better than either latanoprost or timolol in lowering intraocular pressure in black patients. Travoprost is safe and generally well tolerated in the studied patient population. (Am J Ophthalmol 2001;132:472– 484. © 2001 by Elsevier
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safety and efficacy of Travoprost solution for the treatment of elevated intraocular pressure
Clinical Ophthalmology, 2015Co-Authors: Luciano Quaranta, Ivano Riva, Andreas Katsanos, Irene Floriani, Marco Centofanti, Anastasios G P KonstasAbstract:Travoprost is a prostaglandin analogue widely used for reducing intraocular pressure (IOP) in patients affected with glaucoma and ocular hypertension. It exerts its ocular hypotensive effect through the prostaglandin FP receptors, located in the ciliary muscle and the trabecular meshwork. Several studies have shown that topical administration of Travoprost induces a mean IOP reduction ranging from 25% to 32%, and sustained throughout the 24-hour cycle. When compared with timolol, Travoprost is more effective at reducing IOP, while generally no difference has been found in the head-to-head comparison with other prostaglandin analogues. The fixed combination of Travoprost and timolol has demonstrated a hypotensive efficacy comparable to the concomitant administration of the two drugs. Recently, a new preservative-free formulation of Travoprost 0.004% has been marketed for reducing tolerability-related problems in subjects affected with ocular surface disease. Low rates of topical and systemic adverse reactions, strong ocular hypotensive efficacy, and once-a-day dosing make Travoprost a first-line treatment for patients affected with elevated IOP.
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long term 24 hour intraocular pressure control with Travoprost monotherapy in patients with primary open angle glaucoma
Journal of Glaucoma, 2014Co-Authors: Ivano Riva, Andreas Katsanos, Irene Floriani, Marco Centofanti, Anastasios G P Konstas, Elena Biagioli, Luciano QuarantaAbstract:PURPOSE: The aim of the study was to evaluate the long-term 24-hour intraocular pressure (IOP) efficacy of Travoprost monotherapy in primary open-angle glaucoma patients. PATIENTS AND METHODS: A total of 36 previously untreated primary open-angle glaucoma patients were enrolled in this 5-year study. Patients underwent an untreated 24-hour IOP evaluation. Subsequently all patients were assigned to topical therapy with Travoprost 0.004% eye-drops preserved with benzalkonium chloride (Travatan, Alcon Laboratories Inc., Fort Worth, TX) administered once in the evening (8:00 PM) in both eyes. All patients were then scheduled for a 24-hour IOP assessment approximately 12 months after the baseline visit. This schedule of follow-up was maintained for the whole duration of the trial. The predetermined range of target IOP reduction selected in this cohort of patients ranged between 20% and 30%. RESULTS: A total of 34 patients completed all phases of the investigation. The mean survival time was 57.3±2.0 months and the cumulative survival rate was 0.82±0.6 at 60 months. Travoprost reduced the mean 24-hour IOP from 23.4±1.7 mm Hg at baseline to 16.8±2.4 mm Hg (28.4%), 16.8±2.5 mm Hg (28.1%), 16.8±2.4 mm Hg (28.5%), 16.7±2.5 mm Hg (28.6%), and 16.9±2.4 mm Hg (27.8%), respectively at the end of the first, second, third, fourth, and fifth year follow-up. No drug-related serious adverse events were registered during the study. CONCLUSIONS: The present study demonstrated the long-term 24-hour efficacy of Travoprost for the treatment of primary open-angle glaucoma.
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comparison of 24 hour intraocular pressure reduction obtained with brinzolamide timolol or brimonidine timolol fixed combination adjunctive to Travoprost therapy
Journal of Ocular Pharmacology and Therapeutics, 2013Co-Authors: Anastasios G P Konstas, Dimitrios G Mikropoulos, Annabettina Haidich, Gabor Hollo, Theodoros Giannopoulos, Irini C Voudouragkaki, Eleni Paschalinou, Vasileios Konidaris, John R SamplesAbstract:Abstract Background: To determine the adjunctive 24-h efficacy obtained with brinzolamide/timolol, or brimonidine/timolol fixed combinations (FCs) in open-angle glaucoma patients insufficiently controlled on Travoprost monotherapy. Methods: Prospective, observer-masked, active controlled, crossover, comparison. Qualified primary open-angle or exfoliative glaucoma patients with a baseline intraocular pressure (IOP) >18 mm Hg at 10:00 on Travoprost monotherapy were randomized for 3 months to either brinzolamide/timolol, or brimonidine/timolol FC therapy adjunct to Travoprost. Patients were then crossed-over to the opposite therapy for another 3 months. At baseline and at the end of each treatment period, the patients underwent 24-h IOP monitoring. Results: Fifty patients completed the study. The mean 24-h baseline IOP on Travoprost monotherapy was 20.1 mm Hg [95% confidence interval (CI): 19.6, 20.7 mm Hg]. Both adjunctive FC therapies significantly reduced the IOP at each time point and for the mean 24-h I...
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twenty four hour intraocular pressure control with the Travoprost timolol maleate fixed combination compared with Travoprost when both are dosed in the evening in primary open angle glaucoma
British Journal of Ophthalmology, 2009Co-Authors: Anastasios G P Konstas, Dimitrios G Mikropoulos, Annabettina Haidich, Kostantinos S Ntampos, William C StewartAbstract:Objective: To evaluate the 24 h efficacy and safety of the Travoprost/timolol maleate fixed combination (TTFC) versus Travoprost when both are dosed in the evening in primary open-angle glaucoma patients. Methods: Prospective, double-masked, crossover, active-controlled, randomised 24 h comparison. After a 6 week medicine-free period, patients were randomised to either TTFC or Travoprost for 8 weeks and were then switched to the opposite treatment for another 8 weeks. At the end of the washout and treatment periods, a 24 h pressure curve was performed. Results: Thirty-two patients completed the study. The TTFC group demonstrated a lower absolute intraocular pressure level (2.4 mm Hg) for the 24 h curve and at all time points, compared with Travoprost (p⩽0.047). The pressure reduction from untreated baseline was significantly different between treatments for all time points (p = 0.018). The mean 24 h pressure fluctuation was lower with TTFC (3.0 mm Hg) compared with Travoprost (4.0 mm Hg, p = 0.001). No statistical difference existed between the two treatment groups for any adverse event (p>0.05). Conclusions: This study suggests that when both drugs are dosed in the evening the TTFC provides improved intraocular pressure reduction, compared with Travoprost, over the 24 h curve and for each individual time point in primary open-angle glaucoma patients.
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efficacy and safety of latanoprost versus Travoprost in exfoliative glaucoma patients
Ophthalmology, 2007Co-Authors: Anastasios G P Konstas, Vassilios P Kozobolis, Ioannis E Katsimpris, Kostantinos G Boboridis, Stavrenia Koukoula, Jessica N Jenkins, William C StewartAbstract:Objective To evaluate 24-hour intraocular pressure (IOP) efficacy of latanoprost versus Travoprost, each given every evening, in exfoliative glaucoma patients. Design Prospective, observer-masked, crossover comparison. Participants Forty patients with exfoliation glaucoma. Methods Patients with a pressure of >24 mmHg were randomized to latanoprost or Travoprost for an 8-week treatment period after a 6-week medicine-free period. Patients were then switched to the opposite treatment for the second period. At untreated baseline and at the end of each treatment period the IOP was measured at 6 am, 10 am, 2 pm, 6 pm, 10 pm, and 2 am. Main Outcome Measure Diurnal IOP. Results The mean 24-hour IOP was 25.1±2.5 mmHg at baseline, 17.8±2.1 mmHg on latanoprost, and 17.3±2.2 mmHg on Travoprost ( P = 0.001). Individual time points were similar between treatments, except at 6 pm when Travoprost provided lower IOP (16.7±2.6 vs 17.9±2.5 mmHg, P P = 0.03). Conclusions Latanoprost and Travoprost both significantly reduce the 24-hour IOP from baseline in exfoliative glaucoma, but Travoprost may demonstrate a greater hypotensive efficacy in the late afternoon.
