An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

NCT ID: NCT01664039

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

Brief Summary

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

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TRAVATAN

Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months

Group Type: EXPERIMENTAL

Travoprost 0.004% ophthalmic solution

Intervention Type: DRUG

Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative

LUMIGAN

Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months

Group Type: ACTIVE_COMPARATOR

Bimatoprost 0.01% ophthalmic solution

Intervention Type: DRUG

Ophthalmic solution containing benzalkonium chloride (BAK)

Interventions

Travoprost 0.004% ophthalmic solution

Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative

Intervention Type: DRUG

Bimatoprost 0.01% ophthalmic solution

Ophthalmic solution containing benzalkonium chloride (BAK)

Intervention Type: DRUG

Other Intervention Names

TRAVATAN®; LUMIGAN®

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2012-002078-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RDG-11-244

Identifier Type: -

Identifier Source: org_study_id