Status:
COMPLETED
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Lead Sponsor:
Laboratoires Thea
Conditions:
Glaucoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabi...
Detailed Description
The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to: The assessment of the ocular tolerance: * Ocular symptoms *...
Eligibility Criteria
Inclusion
- Written informed consent.
- Association of the 4 following criteria:
- \- Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
- \- With local intolerance signs.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01155219
Start Date
July 1 2008
End Date
December 1 2009
Last Update
April 4 2017
Active Locations (1)
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1
Clermont-Ferrand, France, 63000