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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Geltim LP 1 mg/g; Drug: Xalatan

• Registration Number: NCT01155219
• Lead Sponsor: Laboratoires Thea

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).

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Status Verified: 2010-07
• Study First Posted: 2010-07-01
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-10-24
• Results First Posted: 2014-10-29
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geltim LP®	Geltim LP 1 mg/g	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).
Xalatan®	Xalatan	Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.

Primary Outcome Measures

Name	Time	Method
Ocular Tolerance	Day 84	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.