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

This study has been withdrawn prior to enrollment.
(Change in study design)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00705770
First received: June 24, 2008
Last updated: May 29, 2012
Last verified: July 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00705770     History of Changes
Other Study ID Numbers: C-07-58
Study First Received: June 24, 2008
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open-Angle Glaucoma
Intraocular Pressure
Anecortave Acetate

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014