Comparative study of olopatadine hydrochloride 0.1% and emedastine difumarate 0.05% comparing their clinical efficacy and adverse effects in allergic conjunctivitis

To assess the efficacy and adverse effects of 0.1% Olopatadine hydrochloride [OHC] and compare them to 0.05% Emedastine difumarate [ED] in the treatment of allergic conjunctivitis. Prospective and comparative study. The study was conducted at Islam Teaching Hospital, Islam Medical College, Sialkot from February 2013 to June 2014. 74 adult patients including 35 male patients aged 21- 47 years [Average 32.39] and 39 females aged 20 - 42 years [Average 31.8] some with a history of systemic allergic manifestation [e.g. asthma,dermatitis, or bronchitis] along with sign and symptoms of allergic conjunctivitis were enrolled in the study. At the time of induction, manifestations of allergic conjunctivitis [mucous discharge, itching, conjunctival congestion,chemosis, and watering] were present. Patients were allocate at random to either of the 2 groups, A and B. The patients in the Group A, [n = 36] received OHC and those in the Group B [n = 38] were treated with ED. The dose in Group A was one drop in both the eyes 12 hourly. Group B received one drop in both the eyes 6 hourly. The study was started on the first patient visit, when after the diagnosis; the drug was administered. Patients from both the groups were re-evaluated half an hour, forty eight hours, seven and fourteen days later. Efficacy and side effects in both the groups were assessed. The severity of signs and symptoms were assigned a score from 0 - 3. The results were analysed using independent sample T test. At the start of the study, cumulative score of the patient's sign and symptoms was calculated, with a mean value of 7.31 for group A and 7.38 for group B. There was no significant statistical disparity between the groups [p= 0.88]. The cumulative scores at the end of study on day fourteen were 0.72 for group A and 1.0 for group B. This was also statistically not significant [p = 0.15] but Olopatadine was noted to be more effective. The side effects of both the medicines were similarly assessed with cumulative scores calculated at each follow up. In group A, there were minimal side effects with mean cumulative score on the final visit was 0.25 in group A and0.54 in Group B, with statistically significant [p = 0.015] difference. Olopatadine was discovered to have better efficacy [not statistically significant] and less adverse effects [statistically significant] than Emedastine

Comparação entre o uso tópico do fumarato de cetotifeno 0.025 por cento e do cloridrato de olopatadina 0.1 por cento no tratamento da ceratoconjuntivite primaveril / Comparative study between 0.025 percent ketotifen fumarate and 0.1 percent olopatadine hydrochloride in the treatment of vernal keratoconjunctivitis

OBJETIVO: O objetivo desse estudo foi comparar as soluções oftálmicas de fumarato de cetotifeno 0,025 por cento e de cloridrato de olopatadina 0,1 por cento em pacientes portadores de ceratoconjuntivite primaveril. MÉTODOS: Avaliação realizada em um único centro, simples-cega, comparando-se paralelamente cetotifeno e olopatadina. As medicações foram avaliadas em 4 momentos (dias 1, 7, 14 e 21) por meio de tabelas de graduações padronizadas. A freqüência de eventos adversos foi a principal variável de segurança. RESULTADOS: Na avaliação da evolução do prurido ocular, ardor, lacrimejamento, hiperemia conjuntival, secreção e fotofobia observou-se que o uso tópico do cetotifeno proporcionou melhora significante deste sintoma em relação a olopatadina (p>0,05). Observou-se que a partir do 7° dia de tratamento os pacientes em uso da olopatadina tinham menos ardor, em relação aos que fizeram uso do cetotifeno, mas após o 21° dia essa relação inverteu. Na comparação da sensação de corpo estranho, papilas e pontos de Horner-Trantas evidenciou-se equivalência sem significância estatística. CONCLUSÃO: Concluímos que ambas são drogas equivalentes e atuaram de forma eficaz e segura na remissão dos sintomas relacionados à conjuntivite alérgica primaveril. Houve diferença a favor do cetotifeno (p<0,05) na melhora do prurido, lacrimejamento, hiperemia conjuntival, presença de secreção e fotofobia.

PURPOSE: To compare the topical use of 0.025 percent ketotifen fumarate and 0.1 percent 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.