Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00761709

Last Updated: 2014-07-15

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

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AL-39256

AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Group Type EXPERIMENTAL

AL-39256 Ophthalmic Suspension, 1%

Intervention Type DRUG

XALATAN

Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.

Group Type ACTIVE_COMPARATOR

Latanoprost Ophthalmic Solution, 0.005%

Intervention Type DRUG

Vehicle

Intervention Type DRUG

Inactive ingredients used as a placebo comparator

Vehicle

Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Inactive ingredients used as a placebo comparator

Interventions

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AL-39256 Ophthalmic Suspension, 1%

Intervention Type DRUG

Latanoprost Ophthalmic Solution, 0.005%

Intervention Type DRUG

Vehicle

Inactive ingredients used as a placebo comparator

Intervention Type DRUG

Other Intervention Names

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XALATAN®

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with open-angle glaucoma or ocular hypertension.

Exclusion Criteria

* Females of childbearing potential.
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

Principal Investigators

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Theresa Landry, Ph.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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C-08-28

Identifier Type: -

Identifier Source: org_study_id

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