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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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16 December 2017 |
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Main ID: |
NCT01155219 |
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Date of registration:
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30/06/2010 |
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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, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
T1030 |
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Scientific title:
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Safety and Efficacy Assessment of Geltim LP® 1 mg/g (Unpreserved Timolol Gel - TG1030) in Ocular Hypertensive or Glaucomatous Patients Stabilized by Xalatan® With Ocular Intolerance Signs. |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01155219 |
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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: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent.
- Association of the 4 following criteria:
1. - Bilateral primary open angle glaucoma or bilateral ocular hypertension already
treated and controlled by mono-therapy of Xalatan® (1drop per day),
2. - With local intolerance signs.
Exclusion Criteria:
- Presence of severe objective ocular sign.
- Any ocular hypertension other than primary ocular hypertension or primary chronic open
angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
- Absolute defect in the ten degrees central point of the visual field.
- Best far corrected visual acuity = 1/10.
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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Glaucoma
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Intervention(s)
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Drug: Geltim LP 1 mg/g
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Drug: Xalatan
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Primary Outcome(s)
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Ocular Tolerance
[Time Frame: Day 84]
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Secondary ID(s)
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LTG1030-PIV-12/07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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