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

Sponsor

Alcon Research (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00705770

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma	Drug: Anecortave Acetate Drug: Anecortave Acetate Drug: Anecortave Acetate Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

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
Experimental: 3 Middle dose of study medication	Drug: Anecortave Acetate Middle dose Sustained release depot suspension
Experimental: 4 High dose of study medication	Drug: Anecortave Acetate High dose Sustained release depot suspension

Outcome Measures

Primary Outcome Measures

Mean Intraocular Pressure [6 months]

Secondary Outcome Measures

Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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