Official Title: “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”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Procedure: GSS questionnaire
  • D0, D30 and D84
• Procedure: IOP
  • D0, D30 and D84
• Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION
  • in the evening during 84 days
• Procedure: Visual acuity
  • D0 and D84

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Active
• Other: Procedure

Primary Measures

• A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
  • Time Frame: after 12 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Absolute and relative IOP change after 4 and 12 weeks of treatment
  • Time Frame: week 4 and 12
    Safety Issue?: No
• Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
  • Time Frame: week 12
    Safety Issue?: No

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,

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00230763

Study ID Number: A6641040

ClinicalTrials.gov Identifier: NCT00230763

Health Authority: France: Afssaps - French Health Products Safety Agency

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