A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Study Overview
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Brief Summary
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Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

Official Title
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A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States

Conditions
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Ocular Hypertension, Glaucoma

Intervention / Treatment
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* Drug: latanoprost 0.005%
* Drug: fixed combination latanoprost-timolol
* Drug: timolol 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour). Exclusion Criteria: History of acute angle closure or closed/barely open anterior chamber angle. Current use of contact lenses. Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit. Ocular inflammation/infection occurring within three months prior to pre-study visit. Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions. Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement. Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block. Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. Inability to adhere to treatment/visit plan. Have participated in any other clinical study within one month prior to pre-study visit.

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: Fixed combination of latanoprost 0.005% and timolol 0.5%<br> | Drug: fixed combination latanoprost-timolol<br>* one drop in the morning and placebo in the evening<br>|
| Active Comparator: latanoprost 0.005%<br> | Drug: latanoprost 0.005%<br>* placebo in the morning and latanoprost .005% in the evening<br>|
| Active Comparator: Timolol - 0.5%<br> | Drug: timolol 0.5%<br>* one drop in the morning and evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. |  | 6 months | 
| Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol |  | 6 months | 
| To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 |  | 6 months | 
| To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups |  | 6 months | 
| To describe the IOP development from baseline to Week 26 for all treatment groups |  | 6 months | 
| To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination |  | 6 months | 
| To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 |  | 6 months | 
| To follow the safety variables throughout the study periods. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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timolol, glaucoma, ocular hypertension, Fixed combination latanoprost-timolol, latanoprost