The safety and efficacy of BEPREVE® have not been established in pediatric patients under 3 years of age.
Efficacy in patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.
BEPREVE® demonstrated statistically significant reductions in ocular itching by 1.41 units on the ocular itch score at 3 minutes post-conjunctival allergen challenge (CAC), compared to placebo at visit 5 (onset of action) (p<0.001)1†‡.
Indication and clinical use:
Relevant warnings and precautions:
For more information:
Please consult the Product Monograph at https://pro.bausch.ca/wp-content/uploads/2019/11/bepreve-pm-en.pdf for important information relating to adverse reactions, drug interactions, and dosing information that has not been discussed in this piece. The Product Monograph is also available by calling 1-800-361-4261.
Efficacy was established in one Phase 2/3 and one Phase III, placebo-controlled, double-masked, randomized, conjunctival allergen challenge (CAC) clinical trial where participants were randomly assigned to BEPREVE® 1.5% w/v or placebo. CAC testing was done using multiple allergens, including both seasonal and perennial allergens. Study participants included males and females 10 years of age and older who had a positive history of allergic conjunctivitis. Ocular itching (measured on a 5-point scale, from 0 [none] to 4 [incapacitating itch with an irresistible urge to rub]) was evaluated at 3, 5 and 7 minutes following a CAC. Clinical significance was defined as change of more than one unit on the grading scale at a majority of timepoints evaluated.
Visit 3B required 16 hours between investigational product dosing and CAC test. Visit 4 required 8 hours between investigational product dosing and CAC test. Visit 5 required 15 minutes between investigational product dosing and CAC test.1