An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

Alcon

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Ocular Hypertension

Treatments

Drug: Travoprost 0.004% ophthalmic solution

Drug: Bimatoprost 0.01% ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01664039

RDG-11-244

2012-002078-30 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.