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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01243567 |
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Date of registration:
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17/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
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Scientific title:
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Date of first enrolment:
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June 1, 2010 |
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Target sample size:
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81 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01243567 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Portugal
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Spain
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of primary open-angle glaucoma that has never been treated
- Visual Acuity 20/60 or better in each eye
Exclusion Criteria:
- Eye surgery within 3 months
- Any refractive eye surgery
- Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive
pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of
severe myocardial infarction [heart attack])
- Eye inflammation or eye infection within 3 months
- Eye trauma within 6 months
- Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use
during study
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glaucoma, Open-Angle
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Intervention(s)
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Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
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Drug: latanoprost 0.005% ophthalmic solution
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Primary Outcome(s)
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Change From Baseline in Average Intraocular Pressure (IOP)
[Time Frame: Baseline, Month 3]
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Secondary Outcome(s)
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Change From Baseline IOP
[Time Frame: Baseline, Month 3]
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Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
[Time Frame: Baseline, Month 3]
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Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
[Time Frame: Baseline, Month 3]
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Percentage of Patients Reaching a Predefined Target Pressure Threshold
[Time Frame: Baseline, Month 3]
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Secondary ID(s)
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2009-012799-28
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MAF-AGN-OPH-GLA-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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