NCT01514721

Brief Summary

The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.4 years

First QC Date

January 18, 2012

Last Update Submit

December 2, 2014

Conditions

Glaucoma

Keywords

Open-angle glaucomaOcular hypertensionPigment dispersion glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)

    Goldmann applanation tonometry will be performed at the baseline visit and the 12-week visit to record IOP. Change in IOP will be calculated. IOP will be measured in mmHg.

    12 weeks

Secondary Outcomes (3)

  • Percentage of patients who reach target IOP (≤18mmHg)

    12 weeks

  • Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline

    12 weeks

  • Change in ocular hyperemia score at final visit from baseline

    12 weeks

Study Arms (1)

DuoTrav

EXPERIMENTAL

Travoprost/Timolol Maleate BAK-Free Fixed Combination, 1 drop self-administered in treated eye(s) once a day for 12 weeks

Drug: Travoprost/Timolol Maleate BAK-Free Fixed Combination

Interventions

Travoprost/Timolol Maleate BAK-Free Fixed CombinationDRUG

Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).

Also known as: DuoTrav®
DuoTrav

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.
  • On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
  • IOP between 19 and 35 mmHg at any time of day in at least 1 eye.
  • Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
  • Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.

You may not qualify if:

  • Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.
  • Corneal dystrophies in either eye.
  • Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.
  • Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.
  • Women who are pregnant or lactating.
  • Participation in any other investigational study within 30 days prior to the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigational Site

São Paulo, Brazil

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleOcular Hypertension

Interventions

TravoprostDuotrav

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Abayomi Ogundele, PharmD

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

BR(1)