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Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00069719
First received: September 30, 2003
Last updated: August 4, 2008
Last verified: August 2008
History of Changes
  Purpose

To determine the safety and IOP-lowering ability of a test compound in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Glaucoma therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Study Start Date: February 1999
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
  • logMAR visual acuity not worse than 0.6.

Exclusion Criteria:

  • Clinically relevant ophthalmic or systemic conditions may be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069719

Locations
United States, Texas
Alcon Clinical Trial Sites
Multiple Locations Throughout the US Sponsored by Alcon of, Texas, United States
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00069719     History of Changes
Other Study ID Numbers: C-02-33, C-02-33
Study First Received: September 30, 2003
Last Updated: August 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
open-angle
glaucoma
ocular
hypertension
POAG

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

ClinicalTrials.gov processed this record on May 19, 2013