Adjunctive Study of AL-37807 Ophthalmic Suspension

Phase 2

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Timolol gel forming solution, 0.5%; Drug: AL-37807 ophthalmic suspension, 0.1%; Drug: Latanoprost ophthalmic solution; Other: AL-37807 ophthalmic solution vehicle

• Registration Number: NCT00620256
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2012-12
• Disposition First Submitted: 2012-12-03
• Disposition First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Disposition First Posted: 2012-12-05
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Open-angle glaucoma
• Ocular hypertension
• Must have been on Xalatan for at least 3 months
• VA not worse than 0.60
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Age related
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol	Timolol gel forming solution, 0.5%	Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Timolol	Latanoprost ophthalmic solution	Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807 vehicle	Latanoprost ophthalmic solution	AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807	AL-37807 ophthalmic suspension, 0.1%	AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807	Latanoprost ophthalmic solution	AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807 vehicle	AL-37807 ophthalmic suspension, 0.1%	AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
AL-37807 vehicle	AL-37807 ophthalmic solution vehicle	AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in intraocular pressure	Baseline, up to 4 weeks

Trial Locations

Locations (1)

Contact Alcon Call Center at 1-888-451-3937; 🇺🇸 Fort Worth, Texas, United States