Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.

Study Overview
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Brief Summary
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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 stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.

Detailed Description
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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 Objective ocular signs. The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7).

Official 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.

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Geltim LP 1 mg/g
* Drug: Xalatan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geltim LP®<br>Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days). | Drug: Geltim LP 1 mg/g<br>* one drop in the conjunctival sac of each eye in the morning (84 days).<br>|
| Active Comparator: Xalatan®<br>Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days. | Drug: Xalatan<br>* one drop in the conjunctival sac of each eye in the morning (84 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Tolerance | Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye. | Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilateral Glaucoma, Bilateral ocular hypertension, Bilateral primary open angle glaucoma, Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day), With local intolerance signs in at least one eye