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

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00705770

Purpose

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

Condition	Intervention	Phase
Open-Angle Glaucoma	Drug: Anecortave Acetate Drug: Placebo	Phase II Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Anecortave acetate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean Intraocular Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	May 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo treatment with vehicle	Drug: Placebo Placebo treatment with vehicle
2: Experimental Low dose of study medication	Drug: Anecortave Acetate Low dose Sustained release depot suspension
3: Experimental Middle dose of study medication	Drug: Anecortave Acetate Middle dose Sustained release depot suspension
4: Experimental High dose of study medication	Drug: Anecortave Acetate High dose Sustained release depot suspension

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705770

Locations

United States, Texas
Contact Alcon Call Center for Location Information
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Alcon ( Theresa Landry, Ph.D. )
Study ID Numbers:	C-07-58
Study First Received:	June 24, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00705770
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Open-Angle Glaucoma
Intraocular Pressure
Anecortave Acetate

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009