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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: February 3, 2006
Last updated: March 2, 2012
Last verified: March 2012
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
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00287521

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

Responsible Party: Alcon Research Identifier: NCT00287521     History of Changes
Other Study ID Numbers: C-04-68
Study First Received: February 3, 2006
Last Updated: March 2, 2012

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors processed this record on April 28, 2017