24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

Study Overview
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Brief Summary
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This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.

Official Title
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A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Travoprost/timolol fixed combination, travoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00). Patient has POAG and is older than 29 years The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00) Patient can be safely washed out without risk for significant deterioration Distance best corrected Snellen visual acuity better than 1/10 Patient can understand the instructions and comply to medications Open normal appearing angles Exclusion Criteria: Contraindications to prostaglandins or β-blockers History of lack of response (<10% reduction) to any medication Female of childbearing potential or lactating mother History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 81 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Travoprost/Timolol therapy<br>24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops | Drug: Travoprost/timolol fixed combination, travoprost<br> <br> |
| Active Comparator: Travoprost therapy<br>24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops | Drug: Travoprost/timolol fixed combination, travoprost<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24-hour IOP |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction from baseline |  | 3 months | 
| Mean fluctuation of 24-hour IOP |  | 3 months | 
| Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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travoprost/timolol fixed combination