24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

Study Overview
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Brief Summary
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A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.

Official Title
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24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: treatment with latanoprost/timolol fixed combination
* Drug: latanoprost/timolol fixed combination drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has XFG and is older than 29 years The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00) Patient can be safely washed out without risk for significant deterioration Distance best corrected Snelen visual acuity better than 0.1 No contraindication to prostaglandins or β-blockers No history of lack of response (<10% reduction) to any medication Patient can understand the instructions and comply to medications Open normal appearing angles No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc Exclusion Criteria: History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses Patient is a female of childbearing potential or lactating mother

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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>treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring. | Drug: treatment with latanoprost/timolol fixed combination<br>* dosing in the evening with the two fixed combinations<br>Drug: latanoprost/timolol fixed combination drops<br>* once in the evening<br>|
| Active Comparator: Latanoprost/timolol therapy<br>Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring. | Drug: treatment with latanoprost/timolol fixed combination<br>* dosing in the evening with the two fixed combinations<br>Drug: latanoprost/timolol fixed combination drops<br>* once in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effects with the two medications |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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24-hour IOP, exfoliative glaucoma, travoprost/timolol, latanoprost/timolol, fixed combinations