Purchase this article with an account.
Edward John Meier, Abhijit Narvekar, Kyong Bae, Kenneth N Sall, David Wirta; SAFETY EVALUATION OF OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.77% IN PEDIATRIC SUBJECTS WITH ASYMPTOMATIC EYES. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4890.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose. The objective of this study subgroup analysis was to evaluate the safety profile of olopatadine hydrochloride ophthalmic solution, 0.77% (Olopatadine) in pediatric subjects between ages 2 to 17 years old after 6 weeks of treatment.
Methods. This was a multicenter, randomized, double-masked, vehicle controlled, parallel group study in subjects 2 years of age or older with asymptomatic eyes (NCT01698814). Subjects were randomized to receive either olopatadine 0.77% or vehicle solution dosed in each eye once a day for 6 weeks. Eligible subjects had to be asymptomatic for ocular allergies and other eye conditions. Safety parameters (best-corrected visual acuity, ocular signs, intraocular pressure, dilated fundus examination and vital signs) and adverse events were assessed at Day 0 and weeks 1, 3 and 6; for which descriptive statistics were performed.
Results. A total of 75 pediatric subjects were included in this study. Baseline and demographic characteristics were similar between Olopatadine (n=51) and Vehicle (n=24) groups, with most of the subjects completing the study (94.1% on Olopatadine & 87.5% on Vehicle). No clinically relevant differences were observed in any of the safety parameters between both treatment groups. Of the subjects who experienced treatment-emergent adverse events (AEs) (16 subjects [31.4%] and 6 subjects [25.0%] in the Olopatadine and Vehicle groups, respectively), 8 in the Olopatadine and 2 in the Vehicle group experienced treatment-related AEs. Ocular adverse events (MedDRA SOC Eye disorders, related and nonrelated) observed included abnormal sensation in the eye (4% vs 0%), pruritis (2% vs 0%), irritation (0% vs 4%), foreign body sensation (2% vs 0%) and chalazion (0% vs 4%), in the Olopatadine and Vehicle groups, respectively. No deaths or serious AEs were reported in this study.
Conclusions. Olopatadine 0.77% was well-tolerated, with no safety issues or meaningful trends identified in a pediatric population aged 2 to 17 years.
This PDF is available to Subscribers Only