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. RESULTS AND DISCUSSION: 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.
RCT Entities:
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. RESULTS AND DISCUSSION: 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.