Comparison of efficacy and tolerability of Travatan and Lumigan in patients with ocular hypertension or glaucoma but who never received any glaucoma drugs.

• Conditions: Ocular hypertension or Open angle glaucoma; MedDRA version: 14.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2012-002078-30-SI
• Lead Sponsor: Alcon Research, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-07
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1.Must be at least 18 years of age.
2.Must be diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
3.Must have an IOP between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
4.Must have 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.
5.Must have a baseline a tear film break up time (TBUT) of = 5 seconds.
6.Must have a baseline ocular staining grade of < III (i.e. between 0 and II) based on Oxford scale.
7.In case one eye is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
8.Must be able to follow instructions and be willing and able to attend all study visits.
9.Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
10.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

1.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.
2.Any abnormality preventing reliable applanation tonometry in either eye.
3.Corneal dystrophies in either eye.
4.Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
5.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
6.History of severe dry eye, keratoconjunctivitis sicca, ocular pemphigoid or Stevens-Johnson syndrome.
7.Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
8.History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications)
9.Contact lens wearers are excluded
10.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
11.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
12.Progressive retinal or optic nerve disease from any cause.
13.A history of, or at risk for uveitis or cystoid macular edema (CME).
14.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.
15.Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
16.Women who are pregnant or lactating
17.Unwillingness to risk the possibility of darkened iris or eyelash changes.
18.A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
19.Participation in any other investigational study within 30 days prior to the Screening Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified