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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928590

Enrollment

155

Registered

2009-06-26

Start date

2009-07-31

Completion date

2010-11-30

Last updated

2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open-angle Glaucoma

Keywords

open-angle glaucoma, ocular hypertension, pseudoexfoliation, pigment dispersion

Brief 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.

Interventions

DRUGTravoprost/Timolol Maleate Fixed Combination solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse Events (AEs)	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026