Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure

Study Overview
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Brief Summary
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To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).

Official Title
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Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension

Conditions
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Glaucoma, Primary Open Angle (POAG), Ocular Hypertension

Intervention / Treatment
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* Procedure: GSS questionnaire
* Procedure: IOP
* Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
* Procedure: Visual acuity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, Aged > than equal to 18 years, Patient presenting with an OHT or OAG with an IOP � 21 mmHg, Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to treatment, Exclusion Criteria: Patient currently treated by or having received within the last month any ophthalmic hypotensive agent other than a beta-blocker, Patient presenting any contraindication to latanoprost or timolol, Patient with history of asthma, obstructive broncho-pneumopathy, sinusal bradycardia (pulse rate < 60 bpm), auriculo-ventricular block, cardiac insufficiency, Raynaud disease or any other condition that would preclude the patient from taking the prescribed medication, Patient with known intolerance to benzalkonium chloride or any excipient contained in the trial treatment,

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION<br>* in the evening during 84 days<br>* Other names: XALACOM;|
| Other: Procedure<br> | Procedure: GSS questionnaire<br>* D0, D30 and D84<br>Procedure: IOP<br>* D0, D30 and D84<br>Procedure: Visual acuity<br>* D0 and D84<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population. |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and relative IOP change after 4 and 12 weeks of treatment |  | week 4 and 12 | 
| Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment, |  | week 12 |