A Multi-Dose Study With a Treatment for Open-Angle Glaucoma

May 29, 2012 updated by: Alcon Research
The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication

Exclusion Criteria:

  • Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo treatment with vehicle
Drug: Placebo
Placebo treatment with vehicle
Experimental: 2
Low dose of study medication
Drug: Anecortave Acetate

Low dose

Sustained release depot suspension

Drug: Anecortave Acetate

Middle dose

Sustained release depot suspension

Drug: Anecortave Acetate

High dose

Sustained release depot suspension
Experimental: 3
Middle dose of study medication
Drug: Anecortave Acetate

Low dose

Sustained release depot suspension

Drug: Anecortave Acetate

Middle dose

Sustained release depot suspension

Drug: Anecortave Acetate

High dose

Sustained release depot suspension
Experimental: 4
High dose of study medication
Drug: Anecortave Acetate

Low dose

Sustained release depot suspension

Drug: Anecortave Acetate

Middle dose

Sustained release depot suspension

Drug: Anecortave Acetate

High dose

Sustained release depot suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Intraocular Pressure
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 29, 2012

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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