RESUMO
Ocular allergy is one of the most common disorders of the eye surface. Following diagnosis this condition is typically treated with preparations containing antihistamines. However, anatomy of the eye and its natural protective mechanisms create challenges for ocular drug delivery. Rapid elimination of antihistamine substances due to short residency times following application can lead to insufficient treatment of ocular allergies. With this in mind, the aim of this study was to prepare a controlled ocular delivery system to extend the retention time of olopatadine hydrochloride (OLO) and in doing so to reduce the need for frequent application. We developed extended-release ocular in situ gelling systems for which in vivo retention times were determined in sheep following in vitro characterization and cytotoxicity studies. In vivo results were then compared to commercially available Patanol eye drops. the transparent gels formulated using appropriate amounts of polymers and having longer ocular retention times appear to be a viable alternative to commercially available eye drops.
Assuntos
Animais , Masculino , Feminino , Técnicas In Vitro , Oftalmopatias/patologia , Cloridrato de Olopatadina/efeitos adversos , Geleificantes , Lubrificantes Oftálmicos/farmacocinéticaRESUMO
OBJECTIVE: To compare the efficacy of olopatadine 0.1 % and ketotifen 0.025 % ophthalmic solutions in the treatment of allergic conjunctivitis. METHODS: Forty patients with allergic conjunctivitis were included in the study, they were randomized in two groups: G-I (n = 20) olopatadine 0.1 % and G-II (n = 20) ketotifen 0.025 %, both receiving one drop every 12 hours. We evaluated itching, burning, tearing, redness and chemosis previously and 30 minutes, one, two and four week after. RESULTS: Age G-I was 19.7 +/- 6.7 years; G-II, 21.05 +/- 8.3 years. When evaluating itching, olopatadine had a significant improvement at 30 minutes and after one week (p < 0.05). In the following weeks, the results were similar in both groups. Olopatadine showed significant improvement in burning at 30 minutes, one and two week (p < 0.05). Tearing significantly decreased at 30 minutes with olopatadine (p < 0.05). There was no difference in redness or chemosis improvement in both groups. CONCLUSIONS: In this study, olopatadine 0.1 % was more effective than topical ketotifen 0.025 % in improving itching, tearing and burning in allergic conjunctivitis patients.
Assuntos
Antialérgicos/uso terapêutico , Conjuntivite Alérgica/tratamento farmacológico , Dibenzoxepinas/uso terapêutico , Cetotifeno/uso terapêutico , Feminino , Humanos , Masculino , Cloridrato de Olopatadina , Adulto JovemRESUMO
PURPOSE: To compare the topical use of 0.025% ketotifen fumarate and 0.1% olopatadine hydrochloride in the treatment of patients with vernal keratoconjunctivitis. METHODS: A study performed in one center, simple masked, parallel-group compared ketotifen and olopatadine. These patients were evaluated on four visits during the treatment (days 1, 7, 14 and 21), defined by ratings scores. Adverse events were the main variable of safety rating. RESULTS: On evaluating ocular itching, burning, tearing, conjunctival hyperemia, mucous discharge and photophobia, the ketotifen group showed a significant improvement of total signs and symptoms (p<0.05). Between the baseline and the 2nd visit, treatment with olopatadine resulted in decreased burning, but after the 4th visit, ketotifen was slightly better. Sand sensation, papillae and Horner-Trantas dots were not significantly different in both groups. CONCLUSION: Both drugs were efficient and safe relieving the main symptoms and signs of vernal keratoconjunctivitis. Between the same timepoints, there was a significant difference in favor of ketotifen-treated patients (p<0.05), showing improvement of itching, tearing, conjunctival hyperemia, mucous discharge and photophobia.
Assuntos
Antialérgicos/uso terapêutico , Conjuntivite Alérgica/tratamento farmacológico , Dibenzoxepinas/uso terapêutico , Oftalmopatias/etiologia , Cetotifeno/uso terapêutico , Administração Tópica , Antialérgicos/efeitos adversos , Distribuição de Qui-Quadrado , Criança , Pré-Escolar , Dibenzoxepinas/efeitos adversos , Feminino , Humanos , Cetotifeno/efeitos adversos , Masculino , Cloridrato de Olopatadina , Soluções Oftálmicas/efeitos adversos , Soluções Oftálmicas/uso terapêutico , Prurido/etiologia , Estações do Ano , Método Simples-Cego , Estatísticas não Paramétricas , Lágrimas/efeitos dos fármacos , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: Olopatadine hydrochloride 0.1% ophthalmic solution is a topical antiallergy agent indicated for treatment of the signs and symptoms of allergic conjunctivitis. The purpose of this study was to evaluate the comfort of olopatadine used for contact lens wearers in the conjunctival allergen-challenge (CAC) model. METHODS: This was a single-center, randomized, double-masked, parallel-controlled CAC study. Contact lens-wearing subjects with a history of allergic conjunctivitis were randomized to receive olopatadine or placebo bilaterally. Fifteen minutes after study medication instillation, subjects inserted contact lenses. Allergen challenge was performed 10 minutes after contact lens insertion. Subjective evaluations of ocular comfort were obtained immediately and every minute after CAC, up to and including 10 minutes. Thereafter, comfort evaluations were made every 5 minutes up to and including 60 minutes. Subjects evaluated itching at 3, 7, and 10 minutes and redness was graded at 5, 10, and 20 minutes. All evaluations were graded on standardized scales. Subjects were given diaries in which to rate comfort at 2, 4, 6, 9, 12, and 13 hours and the time of contact lens removal. RESULTS: At post-study medication instillation, post-lens insertion, and at time points from 1 to 10 minutes post-allergen challenge, ocular comfort evaluations were statistically superior in subjects receiving olopatadine as compared with those receiving placebo (P < 0.05). The difference in time until contact lens removal was clinically significant, with subjects who were treated with olopatadine wearing lenses for an average of 2.1 hours longer than placebo group. CONCLUSIONS: As evidenced by significantly greater comfort and longer duration of lens wear, olopatadine provides superior comfort to contact lens wearers suffering from the signs and symptoms of seasonal allergic conjunctivitis, as induced by the CAC model.
Assuntos
Alérgenos/efeitos adversos , Antialérgicos/uso terapêutico , Túnica Conjuntiva/efeitos dos fármacos , Conjuntivite Alérgica/tratamento farmacológico , Lentes de Contato/estatística & dados numéricos , Dibenzoxepinas/uso terapêutico , Antagonistas dos Receptores Histamínicos H1/uso terapêutico , Adulto , Antialérgicos/administração & dosagem , Conjuntivite Alérgica/induzido quimicamente , Conjuntivite Alérgica/fisiopatologia , Dibenzoxepinas/administração & dosagem , Método Duplo-Cego , Avaliação de Medicamentos , Feminino , Antagonistas dos Receptores Histamínicos H1/administração & dosagem , Humanos , Masculino , Modelos Biológicos , Cloridrato de Olopatadina , Soluções Oftálmicas , Satisfação do PacienteRESUMO
PURPOSE: To compare the ocular comfort of two ophthalmic anti-allergic agents: olopatadine hydrochloride 0.1% and ketotifen fumarate 0.05%. SUBJECTS AND METHODS: In a double-masked, multi-centered, randomized trial, 80 subjects were asked to make a 'forced choice' based on ocular comfort between one drop of olopatadine hydrochloride 0.1% instilled in one eye and one drop of ketotifen fumarate 0.05% instilled in the contralateral eye. At one site, the incidence of adverse reactions was also reported. RESULTS: All subjects (100%) selected olopatadine as the more comfortable formulation. One site (n = 35) reported a 49% incidence of moderate burning and a 49% incidence of mild burning after ketotifen instillation. One subject (2% of population) at this site experienced no ocular discomfort with ketotifen. There were no reports of discomfort associated with olopatadine instillation. CONCLUSION: Olopatadine is a more comfortable ophthalmic preparation than ketotifen.