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This study has been withdrawn prior to enrollment.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
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 April 16, 2014