Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Bepotastine Besilate Ophthalmic Solution 1.0%; Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%; Drug: placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586664

CL-S&E-0409071-P

Details and patient eligibility

About

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

Enrollment: 130 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be at least 10 years of age

Exclusion criteria

• No active ocular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 3 patient groups, including a placebo group

Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%

Experimental group

Treatment:

Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%

Bepotastine Besilate Ophthalmic Solution 1.0%

Experimental group

Treatment:

Drug: Bepotastine Besilate Ophthalmic Solution 1.0%

Placebo

Placebo Comparator group

Treatment:

Drug: placebo comparator