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

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Travoprost

U.S. FDA Resources

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.

Estimated Enrollment:	100
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 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

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations	Recruiting
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 4, 2013
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 June 18, 2013