Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Study Overview
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Brief Summary
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The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.

Official Title
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24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Travoprost/timolol therapy
* Drug: Latanoprost/Timolol therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary open-angle glaucoma or exfoliative glaucoma Patients who require additional IOP lowering on latanoprost monotherapy Morning IOP greater than 20 mm Hg on latanoprost monotherapy Untreated morning IOP greater than 26 mm Hg Patients older than 29 years Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio) On therapy with latanoprost monotherapy for at least 3 months Patients with a reliable visual field Best corrected distance Snellen visual acuity >1/10 Corneal pachymetry within the 550 ± 50 μm range Patients should understand the study instructions Patients willing to attend all follow-up appointments and willing to comply with study medication usage Patients who have open, normal appearing angles Exclusion Criteria: History of combined topical therapy Contraindication to prostaglandins or timolol History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses Sign of ocular infection except for mild blepharitis Any corneal abnormality that could have affected the measurement of IOP Chronic use of topical corticosteroids in the last 3 months before entering the study Current, or previous use of systemic corticosteroid treatment Uncontrolled systemic disease Change of a systemic medication during the study period Women of childbearing potential or lactating mothers Inability to understand the instructions and adhere to medications

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 80 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>Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy | Drug: Travoprost/timolol therapy<br>* Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing<br>* Other names: DuoTrav BAK Free;Drug: Latanoprost/Timolol therapy<br>* Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy<br>* Other names: Xalacom;|
| Active Comparator: Latanoprost/Timolol therapy<br>Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy | Drug: Travoprost/timolol therapy<br>* Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing<br>* Other names: DuoTrav BAK Free;Drug: Latanoprost/Timolol therapy<br>* Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy<br>* Other names: Xalacom;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24-hour intraocular pressure reduction between the two medications | Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of adverse events with the two medications | At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health. | 3 months | 
| ocular surface indicators after 3 months of therapy with the two medications | Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface 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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glaucoma, fixed combinations, 24-hour monitoring