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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293787
• Other study ID #: C-04-03
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2006
• Last updated: February 13, 2012
• Start date: June 2004
• Est. completion date: August 2005

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older.

• Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.

• Mean IOP in each eye less than 18 mmHg at the screening visit.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pregnant.

• History of chronic or recurrent severe inflammatory eye disease.

• Ocular trauma within the past six months in either eye.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Other:
• Timolol Vehicle
Placebo

Drug:
• Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
• Timolol Maleate Ophthalmic Solution 0.5%
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean intraocular pressure (IOP) change at 3 months from baseline		3 months	No