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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01062971 |
Date of registration:
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02/02/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
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Scientific title:
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Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension |
Date of first enrolment:
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February 2006 |
Target sample size:
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124 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01062971 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Leopoldo M Baiza-Duran, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Research Department. Laboratorios Sophia S.A de C.V. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult subjects of either sex and any race with open-angle glaucoma or ocular
hypertension;
- Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).
Exclusion Criteria:
- Clinically relevant ophthalmic or systemic conditions may be excluded.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ocular Hypertension
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Primary Open Angle Glaucoma
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Intervention(s)
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Drug: dorzolamide-timolol-brimonidine
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Primary Outcome(s)
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Intraocular Pressure (IOP)
[Time Frame: basal (day 1 ) and final (day 60)]
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Secondary Outcome(s)
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Number of Adverse Events
[Time Frame: basal (day 1 ) and security call (day 75)]
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Secondary ID(s)
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SOPHIA-PRO-122
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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