Safety and Efficacy of Changing to DuoTrav From Prior Therapy

Study Overview
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Brief Summary
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The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.

Official Title
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Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye). Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study. Women who are pregnant or lactating. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator. Corneal dystrophies in either eye. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. History of severe allergic rhinitis. Other protocol-defined 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DuoTrav<br>One drop in study eye(s) once daily for 8 weeks | Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)<br>* One drop in study eye(s) once daily for 8 weeks<br>* Other names: DuoTrav®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline) | Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who reach target IOP (≤18 mmHg) | Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18 mmHg to the overall study population. | 8 weeks |