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Mark B. Abelson - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of single and multiple dose Ketotifen fumarate 0 025 ophthalmic solution in a pediatric population
Pediatric Allergy and Immunology, 2004Co-Authors: Mark B. Abelson, Nancy J Ferzola, Cecilia L Mcwhirter, Henry J CramptonAbstract:Allergic conjunctivitis can seriously disrupt children's daily activities. This study assessed the efficacy (onset and duration of action) and safety of Ketotifen fumarate 0.025% ophthalmic solution compared with vehicle placebo in pediatric subjects after single and multiple dosing. This was a double-masked, multicenter, fellow-eye, placebo-controlled, conjunctival allergen challenge trial. Eligible subjects (8-16-yr-olds) who produced a qualifying reaction to allergen were randomized to a single dose (one drop) of Ketotifen fumarate in one eye and vehicle placebo in the fellow eye, followed by an allergen challenge at 15 min and 8 h post-dose. Subjects who had a qualifying reaction to allergen in the placebo-treated eye and a qualifying response to Ketotifen in the active-treated eye following the single dose were re-randomized to a multiple-dose treatment period. They were instructed to instill one drop of Ketotifen fumarate in one eye and placebo in the other eye twice daily for 4 wk. An allergen challenge was conducted 8 h after the last dose. The primary efficacy assessment was ocular itching, judged by the subject at 3, 7, and 10 min post-allergen challenge after single- and multiple-dose treatments. Other ocular signs and symptoms were assessed at 7, 10, and 15 min post-dose. A total of 133 subjects were randomized to single-dose treatment; 105 were evaluable for efficacy. Of these, 60 were re-randomized to multiple-dose treatment, and 55 were evaluable for efficacy. After single and multiple doses, Ketotifen fumarate significantly inhibited ocular itching compared with placebo at all post-challenge timepoints (p < 0.001) and also significantly reduced hyperemia, chemosis, and lid swelling (p = 0.031). No drug-related systemic adverse events were reported, and ocular adverse events were comparable to placebo. No subject discontinued prematurely due to an adverse event. These results indicate that Ketotifen fumarate 0.025% ophthalmic solution is an effective and safe treatment option for children with allergic conjunctivitis.
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efficacy and safety of Ketotifen fumarate 0 025 in the conjunctival antigen challenge model of ocular allergic conjunctivitis
American Journal of Ophthalmology, 2003Co-Authors: Jack V Greiner, Barry M. Kapik, Naveed B. K. Shams, Thomas K Mundorf, Harvey Dubiner, John Lonsdale, Richard Casey, Leonard M Parver, Mark B. AbelsonAbstract:Abstract Purpose To determine the duration of action of Ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model. Design Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study. Methods Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of Ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received Ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups. Results For both studies, ocular itching and vascular injection were significantly reduced ( P P Conclusions Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.
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efficacy of Ketotifen fumarate 0 025 ophthalmic solution compared with placebo in the conjunctival allergen challenge model
Archives of Ophthalmology, 2003Co-Authors: Mark B. Abelson, Barry M. Kapik, Matthew Jonathan Chapin, Naveed ShamsAbstract:Background Ketotifen fumarate blocks histamine 1 (H 1 ) receptors, stabilizes mast cells, and acts as an eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). Objective To assess the efficacy of Ketotifen 0.025% ophthalmic solution in the prevention of symptoms of allergic conjunctivitis, using the conjunctival allergen challenge model. Methods This was a single-center, double-masked, randomized, placebo-controlled, contralateral-eye comparison, allergen challenge trial conducted in the United States. Subjects were randomized to receive Ketotifen 0.025% in one eye and placebo in the other. At visits 1 and 2, allergen challenges were performed to determine the allergen concentration eliciting a qualifying reaction for each subject. At the 3 subsequent visits, subjects received 1 drop of Ketotifen 0.025% ophthalmic solution in one eye and vehicle solution as placebo in the other eye 15 minutes (visit 3), 6 hours (visit 4), and 8 hours (visit 5) before allergen challenge. The primary efficacy measure was the subject's rating of itching at 3, 7, and 10 minutes after challenge. Results Of the 89 subjects randomly assigned to masked trial medication at visit 3, 72 completed the study. At visits 3, 4, and 5, mean itching scores were significantly better for Ketotifen-treated eyes at all postchallenge time points, compared with placebo ( P P Conclusions Ketotifen was safe and statistically effective in reducing ocular itching and hyperemia associated with allergic conjunctivitis. Ketotifen's rapid onset of action (within 15 minutes) and extended duration of action (at least 8 hours) make it a valuable treatment for allergic conjunctivitis.
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Ocular tolerability and safety of Ketotifen fumarate ophthalmic solution
Advances in Therapy, 2002Co-Authors: Mark B. Abelson, Matthew J. Chapin, Barry M. Kapik, Naveed B. K. ShamsAbstract:Ketotifen fumarate, formulated for the treatment of allergic conjunctivitis, is a histamine H_1-receptor antagonist, mast cell stabilizer, and eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). In this study, healthy volunteers 3 years of age or older received Ketotifen fumarate .025% ophthalmic solution (n = 330) or placebo (n = 165) four times daily for 6 weeks. Ketotifen was safe and well tolerated in the adult and pediatric populations, with an incidence of ocular adverse events of 18.2%, compared with 15.2% with placebo. No ocular rebound vasodilation or itching was observed within 48 hours after treatment. Ketotifen has a favorable safety and tolerability profile, which may have a positive impact on compliance, an important aspect of effective symptomatic control of allergic conjunctivitis.
Naveed Shams - One of the best experts on this subject based on the ideXlab platform.
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efficacy of Ketotifen fumarate 0 025 ophthalmic solution compared with placebo in the conjunctival allergen challenge model
Archives of Ophthalmology, 2003Co-Authors: Mark B. Abelson, Barry M. Kapik, Matthew Jonathan Chapin, Naveed ShamsAbstract:Background Ketotifen fumarate blocks histamine 1 (H 1 ) receptors, stabilizes mast cells, and acts as an eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). Objective To assess the efficacy of Ketotifen 0.025% ophthalmic solution in the prevention of symptoms of allergic conjunctivitis, using the conjunctival allergen challenge model. Methods This was a single-center, double-masked, randomized, placebo-controlled, contralateral-eye comparison, allergen challenge trial conducted in the United States. Subjects were randomized to receive Ketotifen 0.025% in one eye and placebo in the other. At visits 1 and 2, allergen challenges were performed to determine the allergen concentration eliciting a qualifying reaction for each subject. At the 3 subsequent visits, subjects received 1 drop of Ketotifen 0.025% ophthalmic solution in one eye and vehicle solution as placebo in the other eye 15 minutes (visit 3), 6 hours (visit 4), and 8 hours (visit 5) before allergen challenge. The primary efficacy measure was the subject's rating of itching at 3, 7, and 10 minutes after challenge. Results Of the 89 subjects randomly assigned to masked trial medication at visit 3, 72 completed the study. At visits 3, 4, and 5, mean itching scores were significantly better for Ketotifen-treated eyes at all postchallenge time points, compared with placebo ( P P Conclusions Ketotifen was safe and statistically effective in reducing ocular itching and hyperemia associated with allergic conjunctivitis. Ketotifen's rapid onset of action (within 15 minutes) and extended duration of action (at least 8 hours) make it a valuable treatment for allergic conjunctivitis.
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single dose of Ketotifen fumarate 025 vs 2 weeks of cromolyn sodium 4 for allergic conjunctivitis
Advances in Therapy, 2002Co-Authors: Jack V Greiner, Cecilia L Mcwhirter, Clifford Michaelson, Naveed ShamsAbstract:This single-masked, contralateral-eye, active-controlled allergen-challenge study compared Ketotifen fumarate .025% and cromolyn sodium 4% ophthalmic solutions in the prevention of ocular itching, tearing, and redness induced by allergen challenge. After a confirmatory conjunctival provocation test (CPT), 56 patients randomly received masked study medication (placebo in one eye, cromolyn in the other eye) four times daily for 2 weeks. At visit 3, patients received one drop of Ketotifen in the eye previously treated with placebo and cromolyn in the other eye. Ocular comfort was assessed 30 seconds postinstillation, and a CPT was conducted 15 minutes and 4 hours postinstillation to evaluate ocular itching, tearing, and redness. Forty-seven patients were analyzed for efficacy. At the 15-minute and 4-hour challenges, Ketotifen was superior to cromolyn in preventing itching (P<.001) at all assessments and redness (ciliary, conjunctival, and episcleral) (P≤.001 ) at most assessments. Tearing scores were higher in cromolyn-treated eyes than in Ketotifen-treated eyes. Patients reported greater comfort in the Ketotifentreated than in the cromolyn-treated eye (P= .066). The most common adverse event was burning/stinging with cromolyn. A single dose of Ketotifen was superior to a 2-week four-times-daily regimen of cromolyn in alleviating symptoms of allergic conjunctivitis in the conjunctival allergen-challenge model.
Jack V Greiner - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Ketotifen fumarate 0 025 in the conjunctival antigen challenge model of ocular allergic conjunctivitis
American Journal of Ophthalmology, 2003Co-Authors: Jack V Greiner, Barry M. Kapik, Naveed B. K. Shams, Thomas K Mundorf, Harvey Dubiner, John Lonsdale, Richard Casey, Leonard M Parver, Mark B. AbelsonAbstract:Abstract Purpose To determine the duration of action of Ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model. Design Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study. Methods Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of Ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received Ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups. Results For both studies, ocular itching and vascular injection were significantly reduced ( P P Conclusions Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.
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a placebo controlled comparison of Ketotifen fumarate and nedocromil sodium ophthalmic solutions for the prevention of ocular itching with the conjunctival allergen challenge model
Clinical Therapeutics, 2003Co-Authors: Jack V Greiner, George MinnoAbstract:Abstract Background : Ketotifen fumarate 0.025% ophthalmic solution and nedocromil sodium 2.0% ophthalmic solution are 2 topical antiallergic medications with different modes of action and efficacy profiles. Both solutions are indicated for ocular itching associated with allergic conjunctivitis. Objective : This study compared the efficacy, safety, and comfort of Ketotifen fumarate 0.025% ophthalmic solution and nedocromil sodium 2.0% ophthalmic solution for the prevention of ocular itching, using the conjunctival allergen challenge (CAC) model. Methods : This was a single-center, double-masked, contralateral, randomized, placebo- and active-controlled CAC clinical trial. Subjects aged >10 years with a history of allergic hypersensitivity who responded to the CAC at screening visits 1 and 2 qualified for randomization at visit 3. At visit 3 (day 21) and visit 4 (day 35), subjects received 1 of 3 treatments: Ketotifen, nedocromil, or placebo (artificial tears), randomized by eye. Allergen challenges were conducted at 5 minutes posttreatment dose (visit 3) and 12 hours posttreatment dose (visit 4). At each visit, subjects evaluated their ocular itching every 30 seconds for 20 minutes. At visit 4, subjects evaluated the comfort of the medication immediately after instillation, at 30 seconds after instillation, and at l, 2, 5, and 10 minutes after instillation. The subjects were also queried about overall eyedrop comfort by choosing from descriptive terms and about overall eyedrop preference based on comfort and perceived efficacy. Results : Eighty-five subjects were screened for this study. Fifty-nine (28 males, 31 females; mean age, 38.7 years) qualified and were randomized to receive study medications. Ketotifen-treated eyes experienced significantly less ocular itching induced by CAC than nedocromil-treated eyes and those that received placebo at both the 5-minute and 12-hour posttreatment allergen challenges (all P P Conclusion : Ketotifen was significantly more effective and comfortable than nedocromil at both 5 minutes and 12 hours after administration in this CAC model.
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single dose of Ketotifen fumarate 025 vs 2 weeks of cromolyn sodium 4 for allergic conjunctivitis
Advances in Therapy, 2002Co-Authors: Jack V Greiner, Cecilia L Mcwhirter, Clifford Michaelson, Naveed ShamsAbstract:This single-masked, contralateral-eye, active-controlled allergen-challenge study compared Ketotifen fumarate .025% and cromolyn sodium 4% ophthalmic solutions in the prevention of ocular itching, tearing, and redness induced by allergen challenge. After a confirmatory conjunctival provocation test (CPT), 56 patients randomly received masked study medication (placebo in one eye, cromolyn in the other eye) four times daily for 2 weeks. At visit 3, patients received one drop of Ketotifen in the eye previously treated with placebo and cromolyn in the other eye. Ocular comfort was assessed 30 seconds postinstillation, and a CPT was conducted 15 minutes and 4 hours postinstillation to evaluate ocular itching, tearing, and redness. Forty-seven patients were analyzed for efficacy. At the 15-minute and 4-hour challenges, Ketotifen was superior to cromolyn in preventing itching (P<.001) at all assessments and redness (ciliary, conjunctival, and episcleral) (P≤.001 ) at most assessments. Tearing scores were higher in cromolyn-treated eyes than in Ketotifen-treated eyes. Patients reported greater comfort in the Ketotifentreated than in the cromolyn-treated eye (P= .066). The most common adverse event was burning/stinging with cromolyn. A single dose of Ketotifen was superior to a 2-week four-times-daily regimen of cromolyn in alleviating symptoms of allergic conjunctivitis in the conjunctival allergen-challenge model.
Barry M. Kapik - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Ketotifen fumarate 0 025 in the conjunctival antigen challenge model of ocular allergic conjunctivitis
American Journal of Ophthalmology, 2003Co-Authors: Jack V Greiner, Barry M. Kapik, Naveed B. K. Shams, Thomas K Mundorf, Harvey Dubiner, John Lonsdale, Richard Casey, Leonard M Parver, Mark B. AbelsonAbstract:Abstract Purpose To determine the duration of action of Ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model. Design Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study. Methods Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of Ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received Ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups. Results For both studies, ocular itching and vascular injection were significantly reduced ( P P Conclusions Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.
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efficacy of Ketotifen fumarate 0 025 ophthalmic solution compared with placebo in the conjunctival allergen challenge model
Archives of Ophthalmology, 2003Co-Authors: Mark B. Abelson, Barry M. Kapik, Matthew Jonathan Chapin, Naveed ShamsAbstract:Background Ketotifen fumarate blocks histamine 1 (H 1 ) receptors, stabilizes mast cells, and acts as an eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). Objective To assess the efficacy of Ketotifen 0.025% ophthalmic solution in the prevention of symptoms of allergic conjunctivitis, using the conjunctival allergen challenge model. Methods This was a single-center, double-masked, randomized, placebo-controlled, contralateral-eye comparison, allergen challenge trial conducted in the United States. Subjects were randomized to receive Ketotifen 0.025% in one eye and placebo in the other. At visits 1 and 2, allergen challenges were performed to determine the allergen concentration eliciting a qualifying reaction for each subject. At the 3 subsequent visits, subjects received 1 drop of Ketotifen 0.025% ophthalmic solution in one eye and vehicle solution as placebo in the other eye 15 minutes (visit 3), 6 hours (visit 4), and 8 hours (visit 5) before allergen challenge. The primary efficacy measure was the subject's rating of itching at 3, 7, and 10 minutes after challenge. Results Of the 89 subjects randomly assigned to masked trial medication at visit 3, 72 completed the study. At visits 3, 4, and 5, mean itching scores were significantly better for Ketotifen-treated eyes at all postchallenge time points, compared with placebo ( P P Conclusions Ketotifen was safe and statistically effective in reducing ocular itching and hyperemia associated with allergic conjunctivitis. Ketotifen's rapid onset of action (within 15 minutes) and extended duration of action (at least 8 hours) make it a valuable treatment for allergic conjunctivitis.
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Ocular tolerability and safety of Ketotifen fumarate ophthalmic solution
Advances in Therapy, 2002Co-Authors: Mark B. Abelson, Matthew J. Chapin, Barry M. Kapik, Naveed B. K. ShamsAbstract:Ketotifen fumarate, formulated for the treatment of allergic conjunctivitis, is a histamine H_1-receptor antagonist, mast cell stabilizer, and eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). In this study, healthy volunteers 3 years of age or older received Ketotifen fumarate .025% ophthalmic solution (n = 330) or placebo (n = 165) four times daily for 6 weeks. Ketotifen was safe and well tolerated in the adult and pediatric populations, with an incidence of ocular adverse events of 18.2%, compared with 15.2% with placebo. No ocular rebound vasodilation or itching was observed within 48 hours after treatment. Ketotifen has a favorable safety and tolerability profile, which may have a positive impact on compliance, an important aspect of effective symptomatic control of allergic conjunctivitis.
George Bensch - One of the best experts on this subject based on the ideXlab platform.
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randomized double masked placebo controlled comparison of the efficacy of emedastine difumarate 0 05 ophthalmic solution and Ketotifen fumarate 0 025 ophthalmic solution in the human conjunctival allergen challenge model
Clinical Therapeutics, 2002Co-Authors: Peter A Darienzo, Andrea Leonardi, George BenschAbstract:Abstract Background: Emedastine difumarate 0.05% ophthalmic solution and Ketotifen fumarate 0.025% ophthalmic solution are 2 topical antiallergic agents available in the United States and other countries. Emedastine is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis. Ketotifen is indicated for the temporary relief of ocular itching caused by allergic conjunctivitis. Objective: The purpose of this study was to compare the efficacy of these agents in the temporary relief of ocular itching due to allergic conjunctivitis. The 2 agents were compared with each other and with placebo (artificial tears) using the conjunctival allergen challenge (CAC) model. Methods: This was a single-center, randomized, double-masked, placebo-controlled study. At visit 1, CAC was performed on eligible subjects to identify the dose required to elicit a positive allergic reaction. Subjects returned after 7 days for visit 2 to confirm the allergen dose. On day 14 (±3) of the study, enrolled subjects were randomized to 1 of 3 treatment groups: emedastine in 1 eye and placebo in the other, Ketotifen in 1 eye and placebo in the other, or emedastine in 1 eye and Ketotifen in the other. In 25 subjects, bilateral CAC was performed 5 minutes after study medication instillation. In a second group of 20 subjects, CAC was performed 15 minutes after medication instillation. Itching was graded according to a standardized 5-point scale (0 = none to 4=severe itching) at 3, 5, and 10 minutes postchallenge. Differences in efficacy scores between treatments and versus placebo were compared using 2-sample t tests of equal variance. Results: A total of 45 patients (mean age, 41.2 years) received treatment: 16 received emedastine in 1 eye and Ketotifen in the other; 14 received emedastine in 1 eye and placebo in the other; and 15 received Ketotifen in 1 eye and placebo in the other. Both emedastine and Ketotifen significantly inhibited itching ( P Conclusion: The results of this study suggest that emedastine and Ketotifen are not significantly different with respect to anti-itching efficacy in the CAC model of acute allergic conjunctivitis.
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a comparison of the relative efficacy and clinical performance of olopatadine hydrochloride 0 1 ophthalmic solution and Ketotifen fumarate 0 025 ophthalmic solution in the conjunctival antigen challenge model
Clinical Therapeutics, 2000Co-Authors: Gregg J Berdy, George Bensch, Dennis L Spangler, Susan S Berdy, Robert C BrusattiAbstract:Abstract Objective The purpose of this study was to compare the relative efficacy and clinical performance of olopatadine hydrochloride 0.1 % ophthalmic solution and Ketotifen fumarate 0.025% ophthalmic solution in the conjunctival antigen challenge model. Methods This was a prospective, randomized, double-masked, contralaterally controlled, single-center, antigen challenge study. Of the 53 subjects screened, 32 were enrolled and completed the study. The study comprised 3 visits. Primary efficacy variables were ocular itching (assessed at visits 2 and 3) and subject satisfaction (assessed at visit 3). Tolerability variables were slit-lamp findings (all visits), visual acuity (all visits), ocular comfort after drug instillation (visit 3), and adverse events (visits 2 and 3). At visit 1, the antigen concentration that elicited a positive ocular allergic response was determined, and this concentration was confirmed at visit 2. Subjects graded itching on a 5-point scale at 3, 5, and 10 minutes postchallenge. The scores from this visit were used as baseline scores and compared with scores from visit 3 to determine drug efficacy. At visit 3, subjects were randomly assigned to 2 treatment groups. Group A received 1 drop of olopatadine in the right eye and 1 drop of Ketotifen in the left eye. Group B received 1 drop of olopatadine in the left eye and 1 drop of Ketotifen in the right eye. Following drug instillation, the subjects assessed the comfort level in each eye. Twelve hours after instillation, subjects were challenged with the antigen concentration that elicited a positive response at the previous visits. Itching was subjectively graded at 3, 5, and 10 minutes postchallenge. Subjects were asked to choose which therapy they were more satisfied with. Results Twelve hours after administration, efficacy scores for olopatadine were significantly higher than those for Ketotifen at 3 and 5 minutes postchallenge (1.84 and 1.75 vs 1.25 and 1.34; P P Conclusions Olopatadine is more effective than Ketotifen in reducing the itching associated with allergic conjunctivitis in the antigen challenge model. Olopatadine caused less ocular discomfort than Ketotifen and was preferred by ~3 times as many patients as was Ketotifen.
