Status:
COMPLETED
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Glaucoma, Primary Open Angle (POAG)
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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,...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT00230763
Start Date
September 1 2005
End Date
October 1 2007
Last Update
February 18 2021
Active Locations (102)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Agen, France, 47000
2
Pfizer Investigational Site
Amboise, France, 37400
3
Pfizer Investigational Site
Amiens, France, 80000
4
Pfizer Investigational Site
Andrésy, France, 78570