An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

Study Overview
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Brief Summary
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The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.

Official Title
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Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost 0.004% ophthalmic solution
* Drug: Bimatoprost 0.01% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment. Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye. IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. Able to follow instructions and be willing and able to attend all study visits. Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye. Must read, sign, and date an Ethics Committee-approved informed consent form. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. Any abnormality preventing reliable applanation tonometry in either eye. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids. History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications). Contact lens wear. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study. Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating. Unwilling to risk the possibility of darkened iris or eyelash changes. Participation in any other investigational study within 30 days prior to the Screening Visit. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRAVATAN<br>Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months | Drug: Travoprost 0.004% ophthalmic solution<br>* Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative<br>* Other names: TRAVATAN®;|
| Active Comparator: LUMIGAN<br>Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months | Drug: Bimatoprost 0.01% ophthalmic solution<br>* Ophthalmic solution containing benzalkonium chloride (BAK)<br>* Other names: LUMIGAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in IOP at Week 6 and Month 3 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Week 6, Month 3 | 
| Percentage of Subjects Who Reached Target IOP at Each Visit | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Week 6, Month 3, Month 6 | 
| Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Week 6, Month 3, Month 6 | 
| Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 3, Month 6 | 
| Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 3, Month 6 | 
| Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health. | Baseline (Day 0), Month 3, Month 6 | 
| Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 3, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Ocular hypertension