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CompletedNCT00928590Updated Jul 18, 2014

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

A Phase 3 interventional study of Travoprost/Timolol Maleate Fixed Combination solution in Open-angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
155
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Open-angle Glaucoma
  • Ocular Hypertension

Keywords

  • open-angle glaucoma
  • ocular hypertension
  • pseudoexfoliation
  • pigment dispersion
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 155 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    DuoTrav APS

    Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months

    Drug: Travoprost/Timolol Maleate Fixed Combination solution

Interventions

  • DrugTravoprost/Timolol Maleate Fixed Combination solution

    Also known as: DuoTrav APS, DuoTrav (POLYQUAD-preserved)

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00928590
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jun 26, 2009
Start date
Jul 2009
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Jul 18, 2014

Study contacts

Theresa Landry, Ph.D
study director · Alcon Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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