Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Detailed Description
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To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Official Title
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A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
* Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years; IOP=16-30mmHg OH or OAG with visual filed abnormality: ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%, Glaucoma Hemifield Test outside normal limits, Corrected Pattern Standard Deviation with p <5% Exclusion Criteria: Previous damage of anterior chamber angle; ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0; contact lens wearer; severe central field loss; uncontrolled cardiovascular, hepatic or renal disease; any medication within past 1 month.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost 0.004%<br>Travoprost 0.004% | Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)<br>* Travoprost at 9 AM + Placebo & 9 PM<br>|
| Active Comparator: Timolol 0.5%<br>Timolol 0.5% | Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)<br>* Timolol in each eye, twice daily at 9 AM & 9 PM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | At Week 12 - At the 9 AM time point for the patient's worse eye. | 
| Week 12 - Mean IOP At 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | At the 4 PM time point for the patient's worse eye. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP Change From Baseline at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Baseline to Week 12 - at 9 AM | 
| Mean IOP Change at 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Baseline to Week 12 - at 4 PM | 

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