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NCT00293761 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 NCT00293761
Other study ID # C-05-51
Secondary ID
Status Completed
Phase Phase 3
First received February 17, 2006
Last updated November 17, 2016
Start date January 2006
Est. completion date May 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 the 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 109
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Under age 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:
• Travoprost, Investigational
One drop in study eye once daily for 13 days
• Travoprost (TRAVATAN)
One drop in study eye once daily for 13 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

References & Publications (1)

Gross RL, Peace JH, Smith SE, Walters TR, Dubiner HB, Weiss MJ, Ochsner KI. Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma. 2008 Apr-May;17(3):217-22. doi: 10.1097/IJG.0b013e31815a3472. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean IOP
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