Efficacy Study of Travoprost APS Versus TRAVATAN

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in 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; Tetrahydrozoline; Travoprost

Criteria

Inclusion Criteria:

• 18 years of age or older, either gender and any race.

• Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

• Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.

• All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits):

≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential not meeting conditions set in the protocol.

• Severe central visual field loss.

• Angle Shaffer grade < 2.

• Cup/disc ratio > 0.8 (horizontal or vertical measurement).

• Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).

• Intraocular surgery or trauma within last 6 months.

• Any abnormality preventing reliable applanation tonometry.

• History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.

• Allergy/hypersensitivity to study medications.

• Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.

• Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.

• Use of any additional topical or systemic ocular hypotensive medication during the study.

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

• Other protocol-defined exclusion criteria may apply.