A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00788541

Purpose

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

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: Anecortave Acetate Drug: Vehicle	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Anecortave acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, 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: Yes ]

Secondary Outcome Measures:

Percent of patients who remain rescue-medication free [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 1) Placebo treatment with vehicle / low volume	Drug: Vehicle 1) Placebo treatment with vehicle / low volume
2: Placebo Comparator 1) Placebo treatment with vehicle / high volume	Drug: Vehicle 1) Placebo treatment with vehicle / high volume
3: Experimental 3) low dose/low volume of study medication	Drug: Anecortave Acetate 3) low dose/low volume of study medication
4: Experimental 4) low dose/high volume of study medication	Drug: Anecortave Acetate 4) low dose/high volume of study medication
5: Experimental 5) high dose/ low volume of study medication	Drug: Anecortave Acetate 5) high dose/ low volume of study medication
6: Experimental 6) high dose/high volume of study medication	Drug: Anecortave Acetate 6) high dose/high volume of study medication

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months

Exclusion Criteria:

Prior angle surgery in the study eye, severe visual field loss in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788541

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations	Recruiting
Fort Worth, Texas, United States, 76134
Contact: Alcon Call Center

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Alcon Research, Ltd. ( Theresa Landry, Ph.D., Sr. Director, Clinical Science )
Study ID Numbers:	C-08-049
Study First Received:	November 7, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00788541
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

Vascular Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009