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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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19 February 2015 |
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Main ID: |
NCT01159756 |
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Date of registration:
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08/07/2010 |
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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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To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure
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Scientific title:
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Date of first enrolment:
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July 2010 |
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Target sample size:
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468 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01159756 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment
dispersion glaucoma in both eyes.
- Must be willing to discontinue the use of all other ocular hypotensive medications
prior to receiving the study medication for the entire course of the study.
- Must be able to follow instructions and be willing and able to attend all study
visits.
Exclusion Criteria:
- A known medical history of allergy, hypersensitivity or poor tolerance to any
component of Travacom that is deemed clinically significant in the opinion of the
Principle Investigator.
- Any abnormality preventing reliable applanation tonometer in either eye. Corneal
dystrophies.
- Any opacity or subject uncooperativeness that restricts adequate examination of the
ocular fundus or anterior chamber of either eye.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Uncontrolled Intraocular Pressure
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Intervention(s)
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Drug: Travacom
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Primary Outcome(s)
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Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only)
[Time Frame: Baseline to Visit 3 (Week 6-8)]
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Secondary efficacy: Percentage of subjects at target IOP (
[Time Frame: Baseline to Visit 3 (Week 6-8)]
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Safety: Adverse Events.
[Time Frame: Baseline to Visit 3 (Week 6-8)]
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Secondary ID(s)
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SMA-10-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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