Travoprost 3-Month Safety and Efficacy Study

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost

Criteria

Inclusion Criteria:

• Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.

• Qualifying intraocular pressure at both eligibility visits.

• Understand and sign an informed consent form.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.

• Severe central visual field loss in either eye.

• Chronic, recurrent or severe inflammatory eye disease.

• Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).

• Any abnormality preventing reliable applanation tonometry.

• Hypersensitivity to prostaglandin analogs or to any component of the study medications.

• Therapy with another investigational agent within 30 days prior to the Screening Visit.

• Other protocol-defined exclusion criteria may apply.