Status:
TERMINATED
Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination
Lead Sponsor:
Alcon Research
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to: * its individual component...
Detailed Description
This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which includ...
Eligibility Criteria
Inclusion
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
- Other protocol-specified inclusion criteria may apply.
Exclusion
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Any form of glaucoma other than open-angle glaucoma.
- Severe central vision loss in either eye.
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
- Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
- Ocular surgery within the preceding 6 months.
- Ocular laser surgery within the preceding 3 months.
- Any abnormality preventing reliable applanation tonometry.
- Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00961649
Start Date
October 1 2009
End Date
February 1 2010
Last Update
July 4 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.