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

Bausch + Lomb

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Ecabet 2.83%; Drug: Ecabet 3.70%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00198536

ISTA-ECBT-CS01

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

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Agree to avoid systemic & topical ophthalmic meds & disallowed meds
• Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
• Diagnosis of moderate dry eye syndrome

Exclusion criteria

• Uncontrolled ocular or systemic disease that could interfere with study
• Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
• Contraindications or hypersensitivity to use of study meds or components
• Wear contact lenses
• Secondary dry eye to surgery
• Eye surgery (including laser) within 6 months
• Use of systemic or topical ophthalmic meds within 14 days
• Punctal plugs in one or both eyes in place for <45 days
• Permanent occlusion of the lacrimal puncta

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 3 patient groups, including a placebo group

Ecabet 2.83%

Experimental group

Description:

Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.

Treatment:

Drug: Ecabet 2.83%

Ecabet 3.70%

Experimental group

Description:

Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.

Treatment:

Drug: Ecabet 3.70%

Vehicle

Placebo Comparator group

Description:

One drop of vehicle in study eye 4 times daily for 90 days.

Treatment:

Drug: Vehicle