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

Launched by LABORATOIRES THEA · Jun 30, 2010

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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.