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

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01514721
First received: January 18, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 intra-ocular pressure (IOP).


Condition Intervention Phase
Glaucoma
Drug: Travoprost/Timolol Maleate BAK-Free Fixed Combination
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DuoTrav
One drop self-administered in treated eye(s) once a day for 12 weeks
Drug: Travoprost/Timolol Maleate BAK-Free Fixed Combination
Commercially marketed, Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).
Other Name: DuoTrav®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.
  • Be on a stable intra-ocular pressure-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
  • Intra-ocular pressure of between 19 and 35 mmHg at any time of day in at least one eye.
  • Have best corrected visual acuity 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 visual acuity 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514721

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abayomi Ogundele, PharmD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01514721     History of Changes
Other Study ID Numbers: RDG-11-171
Study First Received: January 18, 2012
Last Updated: January 10, 2014
Health Authority: Brazil: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open-angle glaucoma
Ocular hypertension
Pigment dispersion glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Travoprost
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014