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An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

This study is currently recruiting participants.
Verified January 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01664039
First received: August 10, 2012
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is evaluate effects of Travatan versus Lumigan on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN®)
Drug: Bimatoprost 0.01% ophthalmic solution (LUMIGAN®)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change from Baseline in Intraocular Pressure (IOP) at 6 months [ Time Frame: Baseline (Day 0), 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Ocular Hyperemia Grading at 6 months [ Time Frame: Baseline (Day 0), 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Ocular Surface Disease Index at 6 months [ Time Frame: Baseline (Day 0), 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRAVATAN
Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative, one drop to the study eye(s), once a day in the evening, for 6 months
 Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN®)
Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative, one drop to the study eye(s), once a day in the evening, for 6 months
Other Name: TRAVATAN®
Active Comparator: LUMIGAN
Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK), one drop to the study eye(s), once a day in the evening, for 6 months
 Drug: Bimatoprost 0.01% ophthalmic solution (LUMIGAN®)
Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK), one drop to the study eye(s), once a day in the evening, for 6 months
Other Name: LUMIGAN®

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
  • Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
  • IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
  • Able to follow instructions and be willing and able to attend all study visits.
  • Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
  • Must read, sign, and date an Ethics Committee-approved informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
  • Any abnormality preventing reliable applanation tonometry in either eye.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
  • History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
  • Contact lens wear.
  • Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
  • Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
  • Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
  • Unwilling to risk the possibility of darkened iris or eyelash changes.
  • 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: NCT01664039

Contacts
Contact: Severine Durier, Medical Affairs EURMEA Manager + 33 1 47 10 48 43

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01664039     History of Changes
Other Study ID Numbers: RDG-11-244, 2012-002078-30
Study First Received: August 10, 2012
Last Updated: January 4, 2013
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee

Keywords provided by Alcon Research:
Glaucoma
Ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Benzalkonium Compounds
Travoprost
Bimatoprost
Cloprostenol
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013