Adjunctive Study of AL-37807 Ophthalmic Suspension

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: AL-37807 ophthalmic suspension, 0.1%; Drug: Timolol gel forming solution, 0.5%; Other: AL-37807 ophthalmic solution vehicle; Drug: Latanoprost ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620256

C-07-05

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups, including a placebo group

AL-37807

Experimental group

Description:

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

Treatment:

Drug: Latanoprost ophthalmic solution

Drug: AL-37807 ophthalmic suspension, 0.1%

Timolol

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost ophthalmic solution

Drug: Timolol gel forming solution, 0.5%

AL-37807 vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Latanoprost ophthalmic solution

Other: AL-37807 ophthalmic solution vehicle

Drug: AL-37807 ophthalmic suspension, 0.1%