Comparison of efficacy of topical alcaftadine (0.25%) versus olopatadine (0.1%) in allergic conjunctivitis

The most common atopic ocular condition in clinical practice is allergic conjunctivitis. One of the preferred treatment options for allergic Conjunctivitis is anti histamines eye drops. The study purpose is to compare the clinical efficacy between topical alcaftadine 0.25% and olopatadine hydrochloride 0.1% in allergic conjunctivitis patients.A prospective, randomized, open label, parallel group, comparative study was conducted on 60 Patients with bilateral allergic conjunctivitis (30 in each group) after taking an informed written consentand was evaluated from May 2018 to November 2018. Patients were randomized into 2 groups of 30 each, group A received topical Alcaftadine 0.25% twice daily and patients in Group B received topical olopatadine hydrochloride 0.1% twice daily for 2 weeks. The patients were evaluated on first visit (baseline) followed by 7 and 14 day after starting the treatment. At each visit signs and symptoms were evaluated and rated using a scale from 0-3(0-Absent, 1- mild, 2 moderate and 3- severe). The change from baseline in the mean scores of itching, hyperemia, photophobia and tearing on day 14 is the primary outcome variable.: The signs and symptoms of allergic conjunctivitis were reduced by 2 weeks from baseline after using both the drugs. Relative significant efficacy was achieved in alcaftadine group for Itching, hyperemia and photophobia, but not for tearing (p=0.3). When compared to 0.1% olopatadine hydrochloride, 0.25% alcaftadine is more effective in reducing the symptoms of all types of allergic conjunctivitis except those mentioned in exclusion criteria.

PHARMACOKINETIC STUDY OF OLOPATADINE 10 MG EXTENDED RELEASE TABLET IN COMPARISON WITH OLOPATADINE 5 MG IMMEDIATE RELEASE TABLET IN INDIAN POPULATION

Objective: This study was designed to assess the pharmacokinetics of single dose of olopatadine hydrochloride 10 mg extended release (ER) tablet of Ranbaxy laboratories limited (two test formulations) with two doses of Allelock® 5 mg immediate release (IR) tablets of Kyowa Hakko Kogyo Co. Ltd. (reference formulation R), in healthy, adult, Indian male subjects under fed condition. Methods: Fifteen healthy male volunteers, 26.07±6.62 y in age and 57.17±6.68 kg in body weight, were divided into three groups and received either olopatadine hydrochloride 10 mg ER tablet or two doses of Allelock® 5 mg tablets in each period. Blood samples were taken at predetermined time points and plasma concentrations of olopatadine were monitored by liquid chromatography mass spectrometric (LCMS/MS). Pharmacokinetic (PK) parameters AUC0-t, AUC0-24, AUC0-∞, and Cmax were calculated for olopatadine using WinNonlin. A statistical analysis was performed on PK data using SAS system. Results: The ER formulations showed a similar AUC as compared to the IR formulation and there was no statistically significant difference in AUC of test formulation A and B and reference R. The ratios of AUC0-t, AUC0-24 and AUC0-∞ for A/R were 91.08, 94.90 and 91.32 and for B/R were 89.63, 93.95 and 89.63 respectively. The ER formulations reported a higher Cmax value as compared to IR formulation. The ratios of Cmax for A/R and B/R were 151.09 and 167.96 respectively. But these higher Cmax values did not pose any safety issue as there were no serious adverse events reported during the study. Conclusion: In conclusion, we can say that though the study drugs did not meet the bioequivalence criteria set by regulatory agencies, but this study gave an insight about PK properties of olopatadine extended release formulation and given an idea about effect of smoking on the PK profile of olopatadine which can be studied in future.

Comparison of two ophthalmic solutions of olopatadine hydrochloride (0.1%) and epinastine hydrochloride (0.05%) on clinical signs of vernal keratoconjunctivitis and side effects of the two drugs

Background: Vernal keratoconjunctivitis (VKC) is a recurrent, bilateral, external, ocular inflammation primarily affecting young adults living in warm dry climates. The objectives of the research was to compare the two ophthalmic solutions of olopatadine hydrochloride (0.1%) and epinastine hydrochloride (0.05%) on clinical signs of vernal keratoconjuntivitis and to determine side effects of both the drugs.Methods: The study was carried out in 40 patients who attended the out-patient department (OPD) Ophthalmology, Darbhanga Medical College and Hospital, Laheriasarai from July 2007 to December 2008. Forty patients with symptoms of VKC (ocular itching, ropy discharge, papillary hypertrophy, gelatinous thickening and horner-trantas spots were selected and included in our study.Results: Mean score of palpebral hyperemia at 0, 14, 28 and 42 days in olopatadine treated eye were 2.1, 1.4, 0.8 and 0.4 respectively having p value <0.01, and <0.01 and <0.05 respectively, while mean score at same stages in placebo eye were 2.1, 2, 1.9, and 1.5 having value >0.05. Epinastine treated group mean score of palpebral hyperemia were <0.01 and <0.01 respectively in epinastine treated eye whereas in placebo treated eye, mean score were 2.1, 2.0, 1.8 and 1.6 respectively having p value >0.05 in all stages. Statistically insignificant reduction at day 14 while very significant reduction at day 28 and 42 was observed in epinastine treated eye as compared to placebo.Conclusions: The present study had shown that both olopatadine and epinastine were effective in treating clinical signs of VKC as compared to placebo.