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Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

NCT ID: NCT00069706

Last Updated: 2012-02-14

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

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2003-10-31

Brief Summary

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The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

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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-12182 0.003%

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Group Type EXPERIMENTAL

AL-12182 0.003% Ophthalmic Solution

Intervention Type DRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

AL-12182 Solution Vehicle

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Group Type PLACEBO_COMPARATOR

AL-12182 Ophthalmic Solution Vehicle

Intervention Type OTHER

Placebo

Latanoprost

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% Ophthalmic Solution

Intervention Type DRUG

Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

AL-12182 0.01%

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Group Type EXPERIMENTAL

AL-12182 0.01% Ophthalmic Solution

Intervention Type DRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

AL-12182 0.03%

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Group Type EXPERIMENTAL

AL-12182 0.03% Ophthalmic Solution

Intervention Type DRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Interventions

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AL-12182 0.003% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type DRUG

AL-12182 Ophthalmic Solution Vehicle

Placebo

Intervention Type OTHER

Latanoprost 0.005% Ophthalmic Solution

Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type DRUG

AL-12182 0.01% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type DRUG

AL-12182 0.03% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years or older.
* Diagnosis of open-angle glaucoma or ocular hypertension.
* LogMAR visual acuity not worse than 0.6.

Exclusion Criteria

* Clinically relevant ophthalmic or systemic conditions.
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

Other Identifiers

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C-03-25

Identifier Type: -

Identifier Source: org_study_id

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