Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.
Phase 4
Completed
- Conditions
- GlaucomaOcular Hypertension
- Registration Number
- NCT00143208
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP >= 21 mmHG).
- Visual acuity >= 20/200.
Exclusion Criteria
- Closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
- Hystory of ALT within 3 months prior to the baseline visit.
- History of any ocular filtering surgical intervention.
- Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method IOP change from baseline to the 6-month visit.
- Secondary Outcome Measures
Name Time Method Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc). Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc). % reduction of IOP change from baseline to the 6-month visit.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇹Sassari, Italy