Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Glaucoma Clinical Trial

Official title:

Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336569
• Other study ID #: SMA-09-26
• Status: Completed
• Phase: Phase 4
• First received: April 14, 2011
• Last updated: May 17, 2013
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;

• Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);

• On a stable medication regimen for IOP reduction one week prior to the screening visit;

• Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;

• Sign informed consent;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;

• Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;

• Infection in either eye;

• Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;

• Risk for visual field or visual acuity worsening, in the opinion of the investigator;

• Women of childbearing potential;

• Pregnant or lactating women;

• Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.

• Participation in another clinical study within 30 days before the screening visit;

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Travoprost 0.004%/timolol maleate 0.5% fixed combination

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	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 Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)	As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.	Baseline, up to 6 weeks	No