Status:
COMPLETED
Travoprost 3-Month Safety and Efficacy Study
Lead Sponsor:
Alcon Research
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypert...
Detailed Description
This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous o...
Eligibility Criteria
Inclusion
- Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
- Qualifying intraocular pressure at both eligibility visits.
- Understand and sign an informed consent form.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
- Severe central visual field loss in either eye.
- Chronic, recurrent or severe inflammatory eye disease.
- Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
- Any abnormality preventing reliable applanation tonometry.
- Hypersensitivity to prostaglandin analogs or to any component of the study medications.
- Therapy with another investigational agent within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1099 Patients enrolled
Trial Details
Trial ID
NCT01453855
Start Date
November 1 2011
End Date
August 1 2012
Last Update
October 18 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.