Ketotifen Fumarate (ketotifen + fumarate)

Distribution by Scientific Domains


Selected Abstracts


Comparative Study of Clinical Efficacy and Tolerance in Seasonal Allergic Conjunctivitis Management with 0.1% Olopatadine Hydrochloride versus 0.05% Ketotifen Fumarate

ACTA OPHTHALMOLOGICA, Issue 2000
Alejandro J. Aguilar
ABSTRACT. Objective: To compare the clinical efficacy and tolerance of 0.1% olopatadine hydrochloride (OHC) versus 0.05% ketotifen fumarate (KF) in the management of allergic conjunctivitis. Materials and Methods: Eighty adult patients with a history of allergy (allergic conjunctivitis, hay fever, asthmatic bronchitis and dermatitis) that were showing allergic conjunctivitis signs and symptoms (itching, hyperemia, mucous discharge and tearing) at the time of inclusion in this study were evaluated. Patients were divided in two groups, A and B. Group A patients were treated with OHC and group B patients were treated with KF. Both groups received one drop in the affected eye every 12 hrs. The start time of this study was the first patient visit, in which the medication was instilled for the first time. Both groups of patients were evaluated 30 min, 48 hr., 7 days and 14 days later. Local tolerance of each medication was evaluated. Results: Clinical improvement of the signs and symptoms of allergic conjunctivitis occurred in 42.5% to 62.5% of the patients in Group A when assessed 30 min following the first topical ocular dose of olopatadine. However, mucous discharge was not affected. Forty-eight (48) hrs. after the first instillation, improvements in 57.5% to 75% of the patients were shown in every evaluated parameter. After 7 days of treatment, positive clinical results were observed in 80% to 87.5% of the treated patients. Except for the patients that were dismissed from the study before the seventh day of treatment due to the absence of therapeutic response (4/40), all patients satisfactorily completed the therapeutic plan by the seventh day. No intolerance reactions were observed in patients of this group. In Group B patients (KF), clinical improvement of the signs and symptoms measured in the study was shown in 20.0% to 47.5% 30 min after instillation. As observed with olopatadine, no improvement in the number of patients showing mucous discharge was noted at the 30-min time point. At 48 hr. after the first instillation, 27.5% to 48% of patients showed improvement in every evaluated parameter. After 7 days of treatment, improvement was observed in 60% to 75% of patients. On Day 14, positive responses were observed in 67.5% to 75% of patients. Seventeen and one-half percent of the patients were dismissed from the study before the seventh day of treatment due to the absence of a therapeutic response. Approximately 23% of the patients had mild reactions of intolerance (stinging) which was not a cause to discontinue the treatment. Conclusion: Olopatadine hydrochloride controlled allergic conjunctivitis symptoms and signs more rapidly and to a greater extent than ketotifen fumarate. Fewer cases of treatment failure were noted with OHC, and no local intolerance reactions were observed, while KF triggered mild reactions (stinging) in 23% of patients. [source]


Efficacy and safety of single- and multiple-dose ketotifen fumarate 0.025% ophthalmic solution in a pediatric population

PEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 6 2004
Mark B. Abelson
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. [source]


Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial

ACTA OPHTHALMOLOGICA, Issue 5 2009
Mehmet Borazan
Abstract. Purpose:, We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC). Methods:, This was a prospective, randomized, double-blinded and placebo-controlled study. A total of 100 patients with SAC were randomly assigned to one of five groups, in which they were administered olopatadine, ketotifen fumarate, epinastine, emedastine or fluorometholone acetate, instilled twice daily for 2 weeks. One eye of each patient was treated with the study drug and the other was treated with a placebo. Signs and symptoms of allergic conjunctivitis (itching, redness, tearing, chemosis and eyelid swelling) were scored on a 4-point scale. Each symptom was assessed at baseline and then again after 1 and 2 weeks of treatment. Ocular surface variables were assessed by conjunctival impression cytology. Results:, At weeks 1 and 2, all antiallergic agents were significantly more effective than placebo in alleviating itching, redness, tearing, chemosis and eyelid swelling. Fluorometholone acetate was significantly less effective than the other agents in reducing itching and redness at all control visits. Ocular surface findings by impression cytology improved significantly after all treatments compared with placebo. Conclusions:, In patients with SAC, olopatadine, ketotifen, epinastine and emedastine are more efficacious than fluorometholone acetate in preventing itching and redness. All the antiallergic agents gave similar results in terms of reducing tearing, chemosis and eyelid swelling. Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC. [source]


Comparative Study of Clinical Efficacy and Tolerance in Seasonal Allergic Conjunctivitis Management with 0.1% Olopatadine Hydrochloride versus 0.05% Ketotifen Fumarate

ACTA OPHTHALMOLOGICA, Issue 2000
Alejandro J. Aguilar
ABSTRACT. Objective: To compare the clinical efficacy and tolerance of 0.1% olopatadine hydrochloride (OHC) versus 0.05% ketotifen fumarate (KF) in the management of allergic conjunctivitis. Materials and Methods: Eighty adult patients with a history of allergy (allergic conjunctivitis, hay fever, asthmatic bronchitis and dermatitis) that were showing allergic conjunctivitis signs and symptoms (itching, hyperemia, mucous discharge and tearing) at the time of inclusion in this study were evaluated. Patients were divided in two groups, A and B. Group A patients were treated with OHC and group B patients were treated with KF. Both groups received one drop in the affected eye every 12 hrs. The start time of this study was the first patient visit, in which the medication was instilled for the first time. Both groups of patients were evaluated 30 min, 48 hr., 7 days and 14 days later. Local tolerance of each medication was evaluated. Results: Clinical improvement of the signs and symptoms of allergic conjunctivitis occurred in 42.5% to 62.5% of the patients in Group A when assessed 30 min following the first topical ocular dose of olopatadine. However, mucous discharge was not affected. Forty-eight (48) hrs. after the first instillation, improvements in 57.5% to 75% of the patients were shown in every evaluated parameter. After 7 days of treatment, positive clinical results were observed in 80% to 87.5% of the treated patients. Except for the patients that were dismissed from the study before the seventh day of treatment due to the absence of therapeutic response (4/40), all patients satisfactorily completed the therapeutic plan by the seventh day. No intolerance reactions were observed in patients of this group. In Group B patients (KF), clinical improvement of the signs and symptoms measured in the study was shown in 20.0% to 47.5% 30 min after instillation. As observed with olopatadine, no improvement in the number of patients showing mucous discharge was noted at the 30-min time point. At 48 hr. after the first instillation, 27.5% to 48% of patients showed improvement in every evaluated parameter. After 7 days of treatment, improvement was observed in 60% to 75% of patients. On Day 14, positive responses were observed in 67.5% to 75% of patients. Seventeen and one-half percent of the patients were dismissed from the study before the seventh day of treatment due to the absence of a therapeutic response. Approximately 23% of the patients had mild reactions of intolerance (stinging) which was not a cause to discontinue the treatment. Conclusion: Olopatadine hydrochloride controlled allergic conjunctivitis symptoms and signs more rapidly and to a greater extent than ketotifen fumarate. Fewer cases of treatment failure were noted with OHC, and no local intolerance reactions were observed, while KF triggered mild reactions (stinging) in 23% of patients. [source]