Conditions: Glaucoma
Keywords: 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

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 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).

Arms:
arm 1: 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). arm 2: Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.

Interventions: intervention 1: Geltim LP 1 mg/g intervention 2: Xalatan
Intervention descriptions: intervention 1: one drop in the conjunctival sac of each eye in the morning (84 days). intervention 2: one drop in the conjunctival sac of each eye in the morning (84 days).

Protocol document: