Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Beta-blocker monotherapy
* Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DuoTrav<br>Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks. | Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution<br> <br> * Other names: DUOTRAV®;|
| Active Comparator: Beta-blocker<br>Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks. | Drug: Beta-blocker monotherapy<br>* Per participant's current prescribed therapy<br>Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution<br> <br> * Other names: DUOTRAV®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (Day 0), Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure