A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

Official Title
-----------------
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.

Conditions
-----------------
Ocular Hypertension, Glaucoma, Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: i. Fixed combination of latanoprost 0.005% and timolol 0.5%
* Drug: timolol 0.5% ophthalmic solution
* Drug: latanoprost 0.005% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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 (two 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. Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed. Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed). Pregnancy Women of childbearing potential who has not used adequate contraceptive methods during the last three months. 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: i. Fixed combination of latanoprost 0.005% and timolol 0.5%<br>* one drop in the morning and placebo in the evening<br>* Other names: xalacom, xalcom;|
| Active Comparator: timolol 0.5% ophthalmic solution<br>one drop in the morning and evening | Drug: timolol 0.5% ophthalmic solution<br>* one drop in the morning and evening<br>* Other names: timoptic;|
| Active Comparator: latanoprost 0.005% ophthalmic solution<br>placebo in the morning and latanoprost .005% in the evening | Drug: latanoprost 0.005% ophthalmic solution<br>* placebo in the morning and latanoprost .005% in the evening<br>* Other names: xalatan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 treatments at Week 26 |  | 6 Months | 
| To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 |  | 6 Months | 
| To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups |  | 6 Months | 
| To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 |  | 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-angle glaucoma ocular hypertension glaucoma