Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma; Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye); On a stable medication regimen for IOP reduction one week prior to the screening visit; Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye; Sign informed consent; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®; Any abnormality that would preclude the reliable performance of applanation tonometry in either eye; Infection in either eye; Conventional or laser intraocular surgery in either eye 3 months prior to screening visit; Risk for visual field or visual acuity worsening, in the opinion of the investigator; Women of childbearing potential; Pregnant or lactating women; Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant. Participation in another clinical study within 30 days before the screening visit; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DuoTrav<br>Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks | Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination<br> <br> * Other names: DuoTrav;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) | As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. | Baseline, up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma, IOP