NCT00928590

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

June 24, 2009

Last Update Submit

July 16, 2014

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

open-angle glaucomaocular hypertensionpseudoexfoliationpigment dispersion

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AEs)

    12 months

Study Arms (1)

DuoTrav APS

EXPERIMENTAL

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

Travoprost/Timolol Maleate Fixed Combination solutionDRUG
Also known as: DuoTrav APS, DuoTrav (POLYQUAD-preserved)
DuoTrav APS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant, breastfeeding, or not using adequate birth control.
  • Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

TravoprostDuotrav

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Theresa Landry, Ph.D

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 26, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 18, 2014

Record last verified: 2014-07