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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
one drop in the conjunctival sac of each eye in the morning (84 days).
one drop in the conjunctival sac of each eye in the morning (84 days).
Unnamed facility
Clermont-Ferrand, France
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.
Time frame: Day 84
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