Efficacy and Safety Of a New Olopatadine Hydrochloride, 0.77% Ophthalmic Formulation In Patients With Allergic Conjunctivitis Using The Conjunctival Allergen Challenge (CAC) Model (NCT01479374)

2014 ◽  
Vol 133 (2) ◽  
pp. AB277
Author(s):  
Gail Torkildsen ◽  
Thomas Macejko ◽  
Abhijit Narvekar ◽  
Mark Bergmann
Author(s):  
Jayanthi C. R. ◽  
Nanthini R. ◽  
. Vijayalakshmi

Background: Allergic conjunctivitis, an ocular surface inflammatory disease with significant social and economic impact affects approximately 25% of the general population. H1 receptor blockers, mast cell stabilizers and drugs that block cytokine and prostaglandin formation form the treatment armamentarium. Olopatadine hydrochloride and Azelastine hydrochloride are dual-acting selective H1 receptor antagonist with mast-cell stabilizing property. This study was undertaken to assess the efficacy and safety of olopatadine hydrochloride 0.1% and Azelastine hydrochloride 0.05% in allergic conjunctivitis amongst Indians.Methods: After obtaining Institutional Ethics Committee approval and written informed consent, 120 patients diagnosed with allergic conjunctivitis fulfilling the inclusion/exclusion criteria were enrolled in the study. Study was done from April 2014 to June 2015 at Minto eye hospital. Study subjects were treated with olopatadine hydrochloride 0.1% and Azelastine hydrochloride 0.05% eye drops BD for 15 days. Ocular symptoms, instead of and signs and adverse events, if any were recorded on the day 8 and day 15 follow up visits.Results: At the end of the study period, the reduction in the ocular itching score from baseline was higher in the olopatadine group compared to the azelastine group (p<0.002). Similarly, the scores of ocular congestion (p<0.008), foreign body sensation (p<0.009), tearing (p<0.001), erythema (p<0.002) and chemosis (p<0.015) also showed larger reduction in the olopatadine treated patients. The common adverse events encountered in both the groups were stinging after instillation, burning, bitter taste and headache.Conclusions: In allergic conjunctivitis, both olopatadine and azelastine were found to be effective in relieving ocular signs and symptoms, but olopatadine was found to be superior in terms of efficacy, safety and tolerability with minimal side effects.


Sign in / Sign up

Export Citation Format

Share Document