Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Bepreve; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586625

CL-SAF-0405071-P

Details and patient eligibility

About

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Enrollment: 861 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No active ocular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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861 participants in 2 patient groups, including a placebo group

Bepreve

Experimental group

Description:

bepotastine besilate ophthalmic solution 1.5%

Treatment:

Drug: Bepreve

Placebo

Placebo Comparator group

Description:

vehicle

Treatment:

Drug: Placebo