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

NCT ID: NCT00287521

Last Updated: 2012-03-05

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

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-02-28

Brief Summary

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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

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Conditions

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Open-angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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AL-37807 Suspension

Group Type EXPERIMENTAL

AL-37807 Ophthalmic Suspension, 1.0%

Intervention Type DRUG

One drop in the study eye(s) once daily for 28 days

Xalatan

Group Type ACTIVE_COMPARATOR

Latanoprost, 0.005% (Xalatan)

Intervention Type DRUG

One drop in the study eye(s) once daily for 28 days

AL-37807 Vehicle

Group Type PLACEBO_COMPARATOR

AL-37807 Vehicle

Intervention Type OTHER

One drop in the study eye(s) once daily for 28 days

Timolol Maleate

Group Type EXPERIMENTAL

Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%

Intervention Type DRUG

One drop in the study eye(s) once daily for 28 days

Interventions

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AL-37807 Ophthalmic Suspension, 1.0%

One drop in the study eye(s) once daily for 28 days

Intervention Type DRUG

Latanoprost, 0.005% (Xalatan)

One drop in the study eye(s) once daily for 28 days

Intervention Type DRUG

AL-37807 Vehicle

One drop in the study eye(s) once daily for 28 days

Intervention Type OTHER

Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%

One drop in the study eye(s) once daily for 28 days

Intervention Type DRUG

Other Intervention Names

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XALATAN

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension

Exclusion Criteria

* Under 18
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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United States Investigative Sites in Texas and Other States

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-04-68

Identifier Type: -

Identifier Source: org_study_id

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