Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:

A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928590
• Other study ID #: C-09-032
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2009
• Last updated: July 16, 2014
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardGermany: Ethics CommissionBelgium: Institutional Review BoardLatvia: Institutional Review BoardAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to sign an informed consent document.

• Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.

• Stable treatment of an IOP-lowering medication.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pregnant, breastfeeding, or not using adequate birth control.

• Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.

• Other protocol-defined exclusion criteria may apply.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Travoprost/Timolol Maleate Fixed Combination solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)		12 months	Yes