Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Phase 4CompletedNCT02003391

Alcon Research157 enrolled

Overview

The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

Beta-blocker monotherapyDRUG

Per participant's current prescribed therapy

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solutionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a clinical diagnosis of either open angle glaucoma or ocular hypertension. * Currently on beta-blocker monotherapy (for \>30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction. * Have a mean baseline lOP of \>18 mmHg and \<32 mmHg in at least one eye. * Must be able to understand and sign an Informed Consent form. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Use of medication excluded by the protocol. * Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol. * Ocular surgeries or procedures excluded by the protocol. * Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal). * Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator. * Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * Other protocol-specified exclusion criteria may apply.

Outcomes

Primary Outcomes

Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

Time frame: Week 4

Secondary Outcomes

Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.

Time frame: Baseline (Day 0), Week 4

Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

Time frame: Baseline (Day 0), Week 4

Data from ClinicalTrials.gov

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