Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Placebo; Drug: Ecabet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370747

ISTA-ECBT-CS02

Details and patient eligibility

About

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/female at least 18 years of age
• Agree to avoid disallowed medications
• Have a diagnosis of dry eye

Exclusion criteria

• Have chronic systemic inflammation
• Have active seasonal ocular allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups, including a placebo group

Ecabet

Experimental group

Description:

Ophthalmic solution in the Study eye four times daily for 90 days.

Treatment:

Drug: Ecabet

Drug: Ecabet

Placebo

Placebo Comparator group

Description:

Ophthalmic solution in the Study eye four times daily for 90 days.

Treatment:

Drug: Placebo