Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow
Information source: Allergan
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Drug); fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
Summary
A 10 week evaluation, crossover design study including a 3 week washout period between
treatments, to determine the effects of fixed combination brimonidine tartrate 0. 2%/timolol
maleate 0. 5% and fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic
solutions on ocular blood flow as measured by retrobulbar blood flow
Clinical Details
Study design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Primary outcome: retrobulbar blood flow
Secondary outcome: Adverse Events
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age: 30 years or older.
2. Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
3. Best corrected visual acuity at least 20/40 in at least one eye.
Exclusion Criteria:
1. History of acute angle-closure or a narrow, occludable anterior chamber angle by
gonioscopy.
2. History of chronic or recurrent inflammatory eye diseases (e. g., scleritis, uveitis).
3. History or signs of intraocular trauma.
4. Any abnormality preventing reliable applanation tonometry.
5. Current use of any ophthalmic or systemic steroid which may interfere with this
investigation.
6. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Indianapolis, Indiana, United States; Recruiting
Additional Information
Starting date: December 2008
Ending date: December 2009
Last updated: December 17, 2008
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