Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients. (T1030)

Thea Pharma

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Xalatan; Drug: Geltim LP 1 mg/g

Study type: Interventional

Funder types: Industry

Identifiers

NCT01155219

LTG1030-PIV-12/07

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent.

• Association of the 4 following criteria:

  1. • Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
  2. • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Geltim LP®

Experimental group

Description:

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).

Treatment:

Drug: Geltim LP 1 mg/g

Xalatan®

Active Comparator group

Description:

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

Treatment:

Drug: Xalatan