Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost/Timolol Maleate Fixed Combination solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928590

C-09-032

EudraCT Number 2009-013178-42

Details and patient eligibility

About

The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to sign an informed consent document.
• Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
• Stable treatment of an IOP-lowering medication.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Pregnant, breastfeeding, or not using adequate birth control.
• Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

DuoTrav APS

Experimental group

Description:

Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months

Treatment:

Drug: Travoprost/Timolol Maleate Fixed Combination solution