Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: bepotastine besilate ophthalmic solution; Drug: placebo comparator ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01174823

S00041

Details and patient eligibility

About

The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.

Enrollment: 245 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

Exclusion criteria

• No active ocular or nasal infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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245 participants in 2 patient groups, including a placebo group

Bepotastine Besilate Ophthalmic Solution

Experimental group

Treatment:

Drug: bepotastine besilate ophthalmic solution

Placebo

Placebo Comparator group

Treatment:

Drug: placebo comparator ophthalmic solution