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Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy

Primary Purpose

Glaucoma

Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Travoprost/Timolol Maleate BAK-Free Fixed Combination
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • 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.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Alcon Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DuoTrav

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of patients who reach target IOP (≤18mmHg)
Goldmann applanation tonometry will be performed at the 12-week visit to record IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18mmHg to the overall study population.
Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline
An OSDI questionnaire will be completed by the subject at the baseline visit and at the 12-week visit. For each visit, an overall OSDI score will be calculated using individual item responses, and the change in OSDI score from baseline will be calculated.
Change in ocular hyperemia score at final visit from baseline
Ocular hyperemia will be assessed by qualified personnel at the baseline visit and again at the 12-week visit, and change from baseline will be calculated.

Full Information

First Posted
January 18, 2012
Last Updated
December 2, 2014
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01514721
Brief Title
Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy
Official Title
Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DuoTrav
Arm Type
Experimental
Arm Description
Travoprost/Timolol Maleate BAK-Free Fixed Combination, 1 drop self-administered in treated eye(s) once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost/Timolol Maleate BAK-Free Fixed Combination
Other Intervention Name(s)
DuoTrav®
Intervention Description
Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).
Primary Outcome Measure Information:
Title
Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients who reach target IOP (≤18mmHg)
Description
Goldmann applanation tonometry will be performed at the 12-week visit to record IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18mmHg to the overall study population.
Time Frame
12 weeks
Title
Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline
Description
An OSDI questionnaire will be completed by the subject at the baseline visit and at the 12-week visit. For each visit, an overall OSDI score will be calculated using individual item responses, and the change in OSDI score from baseline will be calculated.
Time Frame
12 weeks
Title
Change in ocular hyperemia score at final visit from baseline
Description
Ocular hyperemia will be assessed by qualified personnel at the baseline visit and again at the 12-week visit, and change from baseline will be calculated.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 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. Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abayomi Ogundele, PharmD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigational Site
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy

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