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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Latanoprost; Timolol

Criteria

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,