A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%; Drug: AL-37807 Ophthalmic Suspension, 1.0%; Drug: Latanoprost, 0.005% (Xalatan); Other: AL-37807 Vehicle

• Registration Number: NCT00287521
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Under 18
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol Maleate	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	-
AL-37807 Suspension	AL-37807 Ophthalmic Suspension, 1.0%	-
Xalatan	Latanoprost, 0.005% (Xalatan)	-
AL-37807 Vehicle	AL-37807 Vehicle	-

Primary Outcome Measures

Name	Time	Method
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)	Day 28

Trial Locations

Locations (1)

United States Investigative Sites in Texas and Other States; 🇺🇸 Fort Worth, Texas, United States