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Adjunctive Study of AL-37807 Ophthalmic Suspension

NCT ID: NCT00620256

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Keywords

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Glaucoma Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AL-37807

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

Group Type EXPERIMENTAL

AL-37807 ophthalmic suspension, 0.1%

Intervention Type DRUG

Latanoprost ophthalmic solution

Intervention Type DRUG

Timolol

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

Group Type ACTIVE_COMPARATOR

Timolol gel forming solution, 0.5%

Intervention Type DRUG

Latanoprost ophthalmic solution

Intervention Type DRUG

AL-37807 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

Group Type PLACEBO_COMPARATOR

AL-37807 ophthalmic suspension, 0.1%

Intervention Type DRUG

AL-37807 ophthalmic solution vehicle

Intervention Type OTHER

Latanoprost ophthalmic solution

Intervention Type DRUG

Interventions

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AL-37807 ophthalmic suspension, 0.1%

Intervention Type DRUG

Timolol gel forming solution, 0.5%

Intervention Type DRUG

AL-37807 ophthalmic solution vehicle

Intervention Type OTHER

Latanoprost ophthalmic solution

Intervention Type DRUG

Other Intervention Names

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XALATAN

Eligibility Criteria

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Inclusion Criteria

* Open-angle glaucoma
* Ocular hypertension
* Must have been on Xalatan for at least 3 months
* VA not worse than 0.60

Exclusion Criteria

* Age related
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center at 1-888-451-3937

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-07-05

Identifier Type: -

Identifier Source: org_study_id