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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00287521
First received: February 3, 2006
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: AL-37807 Ophthalmic Suspension, 1.0%
Drug: Latanoprost, 0.005% (Xalatan)
Other: AL-37807 Vehicle
Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0) [ Time Frame: Day 28 ]

Enrollment: 87
Study Start Date: November 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-37807 Suspension Drug: AL-37807 Ophthalmic Suspension, 1.0%
One drop in the study eye(s) once daily for 28 days
Active Comparator: Xalatan Drug: Latanoprost, 0.005% (Xalatan)
One drop in the study eye(s) once daily for 28 days
Other Name: XALATAN
Placebo Comparator: AL-37807 Vehicle Other: AL-37807 Vehicle
One drop in the study eye(s) once daily for 28 days
Experimental: Timolol Maleate Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
One drop in the study eye(s) once daily for 28 days

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 18
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287521

Locations
United States, Texas
United States Investigative Sites in Texas and Other States
Fort Worth, Texas, United States, 76180
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00287521     History of Changes
Other Study ID Numbers: C-04-68
Study First Received: February 3, 2006
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
open
angle
glaucoma
ocular
hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Maleic acid
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013