Safety and tolerability of olopatadine 0.2% in children and adolescents.
OBJECTIVE
The aim of this study was to evaluate the safety of olopatadine hydrochloride ophthalmic solution 0.2% in children and adolescents 3-17 years of age.


METHODS
In this 6-week, randomized, double-masked safety evaluation, eligible subjects with asymptomatic eyes underwent in-office visits at weeks 1, 3, and 6 and were contacted by telephone at weeks 2, 4, and 5. Qualified subjects were assigned randomly in a 2:1 ratio of olopatadine 0.2% to vehicle (identical formation without the active ingredient) for dosing on a once-daily schedule. Safety parameters assessed included adverse events, visual acuity, ocular signs (slit-lamp assessments), dilated fundus examinations, intraocular pressure (IOP), pulse, and blood pressure.


CONCLUSIONS
An evaluation of 126 subjects (age range, 3-17) revealed no clinically relevant treatment-related changes in visual acuity, IOP, slit-lamp assessments, fundus examinations, or cardiovascular parameters. All adverse events reported were mild or moderate.


CONCLUSIONS
Olopatadine 0.2% administered once-daily for 6 weeks is safe and well tolerated in children and adolescent patients.
Lichtenstein
Steven J
SJ
Illinois Eye Center, University of Illinois College of Medicine, Peoria, IL, USA. eyedoc44@aol.com
Pasquine
Terry A
TA
Edwards
Michael R
MR
Wells
David T
DT
Gross
Robert D
RD
Robertson
Stella M
SM
D000293:Adolescent; D018926:Anti-Allergic Agents / Q000009:adverse effects*; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D003990:Dibenzoxepins / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005654:Fundus Oculi; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D000069605:Olopatadine Hydrochloride; D009883:Ophthalmic Solutions; D014792:Visual Acuity / Q000187:drug effects