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NCT00287521 Clinical Trial

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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00287521
Other study ID # C-04-68
Secondary ID
Status Completed
Phase Phase 2
First received February 3, 2006
Last updated March 2, 2012
Start date November 2005
Est. completion date February 2006

Study information
Verified date March 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AL-37807 Ophthalmic Suspension, 1.0%
One drop in the study eye(s) once daily for 28 days
• Latanoprost, 0.005% (Xalatan)
One drop in the study eye(s) once daily for 28 days
Other:
• AL-37807 Vehicle
One drop in the study eye(s) once daily for 28 days
Drug:
• Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
One drop in the study eye(s) once daily for 28 days

Locations
Country Name City State
United States United States Investigative Sites in Texas and Other States Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0) Day 28
See also
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Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
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