To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure

Study Overview
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Brief Summary
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This study is a multi-site, unmasked phase IV study. Travacom(R) is a combination topical ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by complementary mechanisms of action. The safety and efficacy of both travoprost and timolol have been established as single and adjunctive therapy in well-controlled clinical studies in thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The objective of this study is to assess the safety and efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension across India.

Conditions
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Uncontrolled Intraocular Pressure

Intervention / Treatment
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* Drug: Travacom


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 be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. Must be able to follow instructions and be willing and able to attend all study visits. Exclusion Criteria: A known medical history of allergy, hypersensitivity or poor tolerance to any component of Travacom that is deemed clinically significant in the opinion of the Principle Investigator. Any abnormality preventing reliable applanation tonometer in either eye. Corneal dystrophies. Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.

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: Travacom<br>Travacom ophthalmic solution | Drug: Travacom<br>* Travacom ophthalmic solution (1 drop per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only) | To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension. | Baseline to Visit 3 (Week 6-8) | 
| Safety: Adverse Events. | To assess the safety of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension. | Baseline to Visit 3 (Week 6-8) | 
| Secondary efficacy: Percentage of subjects at target IOP (</ 18 mmHg), regardless of prior therapy. | To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension. | Baseline to Visit 3 (Week 6-8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Travacom, Glaucoma, Travoprost, Timolol