NCT01155219

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

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 * 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).

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	Geltim LP 1 mg/g	one drop in the conjunctival sac of each eye in the morning (84 days).
DRUG	Xalatan	one drop in the conjunctival sac of each eye in the morning (84 days).

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-07-01
• Completion: 2009-12-01
• First posted: 2010-07-01
• Last updated: 2017-04-04
• Results posted: 2014-10-29

Locations

1 site across 1 country: France