Glaucoma Clinical Trial
Official title:
Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension
NCT number | NCT00348023 |
Other study ID # | 5179 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | June 30, 2006 |
Last updated | February 7, 2007 |
Verified date | February 2007 |
Source | Innovative Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - · Male or female > 18 years of age - Diagnosis of primary open-angle glaucoma or ocular hypertension - Untreated IOP > 18 mm Hg in each eye at the baseline evaluation - Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: - · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication - Uncontrolled systemic disease - Active ocular disease other than POAG or ocular hypertension - Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted) - History of intraocular surgery within the last 3 months - Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind
Country | Name | City | State |
---|---|---|---|
United States | Dr. Noecker | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Innovative Medical |
United States,
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