Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: brimonidine tartrate/timolol fixed combination ophthalmic solution (Drug); brimonidine tartrate ophthalmic solution (Drug); timolol ophthalmic solution (Drug); fixed combination vehicle (Other)
Phase: N/A
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed
combination (CombiganŽ) compared with brimonidine tartrate (AlphaganŽ) and timolol in
patients with glaucoma or ocular hypertension who do not respond well to topical beta
blockers.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive
to topical beta blockers
- No anticipated wearing of contact lenses during study
Exclusion Criteria:
- Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular
infections or severe dry eye)
- Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
- Required regular use of other ocular medications except for occasional use of
artificial tears
Locations and Contacts
Guangzhou, Guangdong, China
Additional Information
Starting date: October 2010
Last updated: August 15, 2012
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