Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis

Bausch + Lomb

Status and phase: Completed; Phase 3; Phase 2

Conditions: Conjunctivitis, Allergic

Treatments: Drug: Placebo; Drug: Bepreve; Drug: Bepotastine Besilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424398

ISTA-BEPO-CS01

Details and patient eligibility

About

The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis

Enrollment: 107 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 10 years of age & either sex, any race
• Willing and able to follow all instructions and attend all study visits
• Positive history of ocular allergies

Exclusion criteria

• Have planned surgery during trial period
• Female currently pregnant, planning a pregnancy, or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 3 patient groups, including a placebo group

Bepreve

Experimental group

Description:

Bepotastine Besilate Ophthalmic Solution 1.5%

Treatment:

Drug: Bepreve

Placebo

Placebo Comparator group

Description:

sterile ophthalmic solution

Treatment:

Drug: Placebo

Bepotastine Besilate

Experimental group

Description:

sterile ophthalmic solution 1.0%

Treatment:

Drug: Bepotastine Besilate