Phase 3 N=861 Randomized Double-blind Treatment

Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Allergic Conjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT00586625 ↗

Enrolled (actual)

861

Serious AEs

0.0%

Results posted

Nov 2009

Primary outcome: Primary: Ocular Comfort — 0.13; 0.07; 0.06; 0.02 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bepreve (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 3+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Ocular Comfort	0.13; 0.07; 0.06; 0.02; 0.1; 0.06	—

Summary

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Eligibility Criteria

Inclusion Criteria

Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria

No active ocular disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00586625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.