Ophthalmic Solution

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Gillian M. Keating - One of the best experts on this subject based on the ideXlab platform.

  • Lifitegrast Ophthalmic Solution 5%: A Review in Dry Eye Disease.
    Drugs, 2017
    Co-Authors: Gillian M. Keating
    Abstract:

    Lifitegrast is a novel small molecule integrin antagonist that blocks the binding of intercellular adhesion molecule 1 (ICAM-1) to lymphocyte function-associated antigen 1 (LFA-1). Lifitegrast Ophthalmic Solution 5% (Xiidra™) was recently approved in the USA for the treatment of dry eye disease. The efficacy of lifitegrast Ophthalmic Solution 5% was compared with vehicle in a 12-week phase 2 study and three 12-week phase 3 studies (OPUS-1, OPUS-2 and OPUS-3) in patients with dry eye disease. Taken as a whole, results of these trials support the treatment effect of lifitegrast Ophthalmic Solution 5% in improving a symptom of dry eye disease (i.e. the change from baseline to day 84 in the eye dryness visual analogue scale score) and a sign of dry eye disease (i.e. the change from baseline to day 84 in the inferior corneal fluorescein staining score). Lifitegrast Ophthalmic Solution 5% was generally well tolerated. In conclusion, lifitegrast Ophthalmic Solution 5% provides a new option for the treatment of dry eye disease.

  • Tafluprost Ophthalmic Solution 0.0015 %: A Review in Glaucoma and Ocular Hypertension
    Clinical Drug Investigation, 2016
    Co-Authors: Gillian M. Keating
    Abstract:

    Tafluprost Ophthalmic Solution 0.0015 % preserved with benzalkonium chloride (BAK) 0.001 % is available in several Asian countries, including Japan. In pivotal trials, BAK-preserved tafluprost Ophthalmic Solution 0.0015 % lowered intraocular pressure (IOP) more effectively than placebo in Asian patients with normal-tension glaucoma and was at least as effective as latanoprost Ophthalmic Solution 0.005 % in Asian patients with primary open-angle glaucoma or ocular hypertension. In other prospective studies in Asian patients with glaucoma or ocular hypertension, tafluprost Ophthalmic Solution 0.0015 % was at least as effective as latanoprost Ophthalmic Solution 0.005 % or travoprost Ophthalmic Solution 0.004 % in terms of IOP lowering, and was considered easier to use and/or store. The efficacy of tafluprost Ophthalmic Solution 0.0015 % was maintained in the longer term. Tafluprost Ophthalmic Solution 0.0015 % was generally well tolerated. In conclusion, BAK-preserved tafluprost Ophthalmic Solution 0.0015 % remains a useful option for the treatment of Asian patients with glaucoma and ocular hypertension.

  • Tafluprost Ophthalmic Solution 0.0015 %: A Review in Glaucoma and Ocular Hypertension.
    Clinical drug investigation, 2016
    Co-Authors: Gillian M. Keating
    Abstract:

    Tafluprost Ophthalmic Solution 0.0015 % preserved with benzalkonium chloride (BAK) 0.001 % is available in several Asian countries, including Japan. In pivotal trials, BAK-preserved tafluprost Ophthalmic Solution 0.0015 % lowered intraocular pressure (IOP) more effectively than placebo in Asian patients with normal-tension glaucoma and was at least as effective as latanoprost Ophthalmic Solution 0.005 % in Asian patients with primary open-angle glaucoma or ocular hypertension. In other prospective studies in Asian patients with glaucoma or ocular hypertension, tafluprost Ophthalmic Solution 0.0015 % was at least as effective as latanoprost Ophthalmic Solution 0.005 % or travoprost Ophthalmic Solution 0.004 % in terms of IOP lowering, and was considered easier to use and/or store. The efficacy of tafluprost Ophthalmic Solution 0.0015 % was maintained in the longer term. Tafluprost Ophthalmic Solution 0.0015 % was generally well tolerated. In conclusion, BAK-preserved tafluprost Ophthalmic Solution 0.0015 % remains a useful option for the treatment of Asian patients with glaucoma and ocular hypertension.

  • diquafosol Ophthalmic Solution 3 a review of its use in dry eye
    Drugs, 2015
    Co-Authors: Gillian M. Keating
    Abstract:

    Diquafosol Ophthalmic Solution 3 % (Diquas®) is a P2Y2 receptor agonist that promotes tear fluid and mucin secretion and is currently approved in Japan and South Korea for the treatment of dry eye. In randomized, double-blind, multicentre trials in patients with dry eye, significantly greater improvements in fluorescein and rose bengal staining scores were seen with diquafosol Ophthalmic Solution 3 % than with placebo, and diquafosol Ophthalmic Solution 3 % was noninferior to sodium hyaluronate Ophthalmic Solution 0.1 % in terms of the improvement in the fluorescein staining score and more effective than sodium hyaluronate Ophthalmic Solution 0.1 % in terms of the improvement in the rose bengal staining score. The efficacy of diquafosol Ophthalmic Solution 3 % in the treatment of dry eye was maintained in the longer term, with improvements also seen in subjective dry eye symptoms, and was also shown in a real-world setting. Diquafosol Ophthalmic Solution 3 % also demonstrated efficacy in various specific dry eye disorders, including aqueous-deficient dry eye, short tear film break-up time dry eye, obstructive meibomian gland dysfunction, dry eye following laser in situ keratomileusis surgery and dry eye following cataract surgery, as well as in contact lens wearers and visual display terminal users. Diquafosol Ophthalmic Solution 3 % was generally well tolerated in patients with dry eye, with eye irritation the most commonly reported adverse event. In conclusion, diquafosol Ophthalmic Solution 3 % is a useful option for the treatment of dry eye.

  • Diquafosol Ophthalmic Solution 3 %: A Review of Its Use in Dry Eye
    Drugs, 2015
    Co-Authors: Gillian M. Keating
    Abstract:

    Diquafosol Ophthalmic Solution 3 % (Diquas®) is a P2Y2 receptor agonist that promotes tear fluid and mucin secretion and is currently approved in Japan and South Korea for the treatment of dry eye. In randomized, double-blind, multicentre trials in patients with dry eye, significantly greater improvements in fluorescein and rose bengal staining scores were seen with diquafosol Ophthalmic Solution 3 % than with placebo, and diquafosol Ophthalmic Solution 3 % was noninferior to sodium hyaluronate Ophthalmic Solution 0.1 % in terms of the improvement in the fluorescein staining score and more effective than sodium hyaluronate Ophthalmic Solution 0.1 % in terms of the improvement in the rose bengal staining score. The efficacy of diquafosol Ophthalmic Solution 3 % in the treatment of dry eye was maintained in the longer term, with improvements also seen in subjective dry eye symptoms, and was also shown in a real-world setting. Diquafosol Ophthalmic Solution 3 % also demonstrated efficacy in various specific dry eye disorders, including aqueous-deficient dry eye, short tear film break-up time dry eye, obstructive meibomian gland dysfunction, dry eye following laser in situ keratomileusis surgery and dry eye following cataract surgery, as well as in contact lens wearers and visual display terminal users. Diquafosol Ophthalmic Solution 3 % was generally well tolerated in patients with dry eye, with eye irritation the most commonly reported adverse event. In conclusion, diquafosol Ophthalmic Solution 3 % is a useful option for the treatment of dry eye.

Marina Bejanian - One of the best experts on this subject based on the ideXlab platform.

  • bimatoprost 0 03 timolol 0 5 preservative free Ophthalmic Solution versus bimatoprost 0 03 timolol 0 5 Ophthalmic Solution ganfort for glaucoma or ocular hypertension a 12 week randomised controlled trial
    British Journal of Ophthalmology, 2014
    Co-Authors: Ivan Goldberg, Rhett M Schiffman, Charlie Liu, Rafael Gil Pina, Aitor Lanzagortaaresti, Marina Bejanian
    Abstract:

    Aim To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) Ophthalmic Solution with bimatoprost 0.03%/timolol 0.5% Ophthalmic Solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098.

  • bimatoprost 0 03 preservative free Ophthalmic Solution versus bimatoprost 0 03 Ophthalmic Solution lumigan for glaucoma or ocular hypertension a 12 week randomised double masked trial
    British Journal of Ophthalmology, 2013
    Co-Authors: Douglas G. Day, Rhett M Schiffman, Thomas R Walters, Gail F. Schwartz, Thomas K Mundorf, Charlie Liu, Marina Bejanian
    Abstract:

    Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) Ophthalmic Solution versus bimatoprost 0.03% (Lumigan) Ophthalmic Solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

  • Bimatoprost 0.03% preservative-free Ophthalmic Solution versus bimatoprost 0.03% Ophthalmic Solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial
    The British journal of ophthalmology, 2013
    Co-Authors: Douglas G. Day, Rhett M Schiffman, Thomas R Walters, Gail F. Schwartz, Thomas K Mundorf, Charlie Liu, Marina Bejanian
    Abstract:

    Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) Ophthalmic Solution versus bimatoprost 0.03% (Lumigan) Ophthalmic Solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

Rhett M Schiffman - One of the best experts on this subject based on the ideXlab platform.

  • bimatoprost 0 03 timolol 0 5 preservative free Ophthalmic Solution versus bimatoprost 0 03 timolol 0 5 Ophthalmic Solution ganfort for glaucoma or ocular hypertension a 12 week randomised controlled trial
    British Journal of Ophthalmology, 2014
    Co-Authors: Ivan Goldberg, Rhett M Schiffman, Charlie Liu, Rafael Gil Pina, Aitor Lanzagortaaresti, Marina Bejanian
    Abstract:

    Aim To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) Ophthalmic Solution with bimatoprost 0.03%/timolol 0.5% Ophthalmic Solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098.

  • bimatoprost 0 03 preservative free Ophthalmic Solution versus bimatoprost 0 03 Ophthalmic Solution lumigan for glaucoma or ocular hypertension a 12 week randomised double masked trial
    British Journal of Ophthalmology, 2013
    Co-Authors: Douglas G. Day, Rhett M Schiffman, Thomas R Walters, Gail F. Schwartz, Thomas K Mundorf, Charlie Liu, Marina Bejanian
    Abstract:

    Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) Ophthalmic Solution versus bimatoprost 0.03% (Lumigan) Ophthalmic Solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

  • Bimatoprost 0.03% preservative-free Ophthalmic Solution versus bimatoprost 0.03% Ophthalmic Solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial
    The British journal of ophthalmology, 2013
    Co-Authors: Douglas G. Day, Rhett M Schiffman, Thomas R Walters, Gail F. Schwartz, Thomas K Mundorf, Charlie Liu, Marina Bejanian
    Abstract:

    Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) Ophthalmic Solution versus bimatoprost 0.03% (Lumigan) Ophthalmic Solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

  • safety and efficacy of ketorolac tromethamine 0 4 Ophthalmic Solution in post photorefractive keratectomy patients
    Journal of Cataract and Refractive Surgery, 2004
    Co-Authors: Kerry D Solomon, Michael B Raizman, Eric D Donnenfeld, Helga P Sandoval, Katherine L Stern, Amanda M Vandenburgh, Janet K Cheetham, Rhett M Schiffman
    Abstract:

    Abstract Purpose: To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% Ophthalmic Solution in postoperative photorefractive keratectomy (PRK) patients. Setting: Fifteen clinical sites in the eastern and southern United States. Methods: This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% Ophthalmic Solution (Acular® LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded. Results: There was significantly less pain intensity experienced by patients in the ketorolac group (P Conclusion: Ketorolac 0.4% Ophthalmic Solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.

Jodi Luchs - One of the best experts on this subject based on the ideXlab platform.

S Tsukahara - One of the best experts on this subject based on the ideXlab platform.

  • Effect of non-steroidal anti-inflammatory Ophthalmic Solution on intraocular pressure reduction by latanoprost in patients with primary open angle glaucoma or ocular hypertension
    The British journal of ophthalmology, 2006
    Co-Authors: Tatsuya Chiba, Kenji Kashiwagi, Nami Chiba, S Tsukahara
    Abstract:

    Aim: To investigate the effects of a non-steroidal anti-inflammatory drug (NSAID) Ophthalmic Solution on latanoprost induced intraocular pressure (IOP) reduction in glaucoma patients. Methods: Examination was conducted on 16 eyes of 16 glaucoma patients who had been given only latanoprost for at least 6 weeks. The NSAID Ophthalmic Solution, sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, was additionally given for 12 weeks into one eye (NSAID group), while sodium hyaluronic acid Ophthalmic Solution was administered into the other eye (control group) in a double masked fashion. The IOP measurement was performed before the start of additional administration of Ophthalmic Solutions, 2, 4, 6, 8, 10, and 12 weeks after the start of additional administration, and 2, 4, and 6 weeks after discontinuing additional administration. Results: No significant difference was observed in the IOPs before additional administration of Ophthalmic Solution between the NSAID group and the control group. Following the additional administration of Ophthalmic Solution, IOP in the NSAID group was consistently higher than that in the control group, and a maximum difference in IOP between the two groups was 1.08 (SD 1.75) mm Hg (p = 0.03). This trend was observed even after additional administration was discontinued. Conclusion: NSAID Ophthalmic Solution may partly affect IOP reduction by latanoprost.

  • Effect of non-steroidal anti-inflammatory Ophthalmic Solution on intraocular pressure reduction by latanoprost
    The British journal of ophthalmology, 2003
    Co-Authors: Kenji Kashiwagi, S Tsukahara
    Abstract:

    Aim: To investigate the effects of a non-steroidal anti-inflammatory drug (NSAID) Ophthalmic Solution on latanoprost induced intraocular pressure (IOP) reduction using normal volunteers. Methods: This study was conducted as a prospective and observer masked clinical trial. 13 normal volunteers were enrolled. After measurement of basal IOP and Ophthalmic examination, latanoprost Ophthalmic Solution was initially administered to both eyes once daily. Four weeks later, an NSAID Ophthalmic Solution, sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate (refer to bromfenac sodium hydrate), was co-administered to one randomly selected eye (NSAID group) twice daily for 2 weeks. The other eye was employed as a control (non-NSAID group). After withdrawal of the NSAID Ophthalmic Solution, latanoprost Ophthalmic Solution was continuously administered for another 2 weeks and was then withdrawn. After a 4 week washout, only bromfenac sodium hydrate Ophthalmic Solution was administered to the eyes of the NSAID group for 2 weeks. During the study period, Ophthalmic examination, including IOP measurement was performed in an observer masked fashion. Results: Before initiation of bromfenac sodium hydrate, baseline IOPs of the non-NSAID group and the NSAID group were 15.73 (SD 1.97) mm Hg and 15.86 (2.06) mm Hg, respectively (p=0.88). Although latanoprost Ophthalmic Solution significantly reduced IOP in both groups, co-administration of bromfenac sodium hydrate significantly inhibited latanoprost induced IOP reduction compared with the non-NSAID group. The IOPs of the non-NSAID and NSAID groups were 10.18 (1.17) mm Hg and 11.63 (1.35) mm Hg with a 2 week co-administration, respectively (p Conclusion: These results indicate that NSAID Ophthalmic Solution may interfere with IOP reduction by latanoprost Ophthalmic Solution in normal volunteers and that we should take this into account when treating patients with glaucoma using latanoprost Ophthalmic Solution.