Estudio multicéntrico, doble enmascarado, de doce meses con la combinación fija de Travoprost/Brinzolamida QD AM y la combinación fija de Travoprost/Brinzolamida QD PM versus COSOPT BID en pacientes con glaucoma de ángulo abierto o hipertensión ocular.A twelve-month, multicenter, double-masked study of Travoprost / Brinzolamide fixed combination QD AM and Travoprost / Brinzolamide fixed combination QD PM versus COSOPT BID in patients with open-angle glaucoma or ocular hypertension - Travoprost / Brinzolamide Fixed Combination Once-Daily vs. COSOPT

Phase 1

• Conditions: Glaucoma de ángulo abierto o hipertensión ocularOpen-angle glaucoma or Ocular hypertension; MedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucoma; MedDRA version: 9.1Level: PTClassification code 10030348Term: Open angle glaucoma; MedDRA version: 9.1Level: SOCClassification code 10015919Term: Eye disorders; MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension; MedDRA version: 9.1Level: PTClassification code 10030043Term: Ocular hypertension

• Registration Number: EUCTR2008-002781-66-ES
• Lead Sponsor: Alcon Research, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-24
• Study Completion: 2009-01-27
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Patients of either sex and any race, 18 years of age or older, diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.

Patients inadequately controlled on a current stable (i.e., at least 4 weeks) IOP lowering medication. Inadequately controlled is defined as having a mean IOP = 18 mmHg in at least one eye at the Screening Visit.

Patients must meet the following IOP entry criteria in at least one eye: For each qualifying eye, the mean IOP must be: = 24 mmHg and = 36 mmHg at the 9:00 time point at both Eligibility Visits 1 and 2, and = 21 mmHg and = 36 mmHg at the 11:00 and 16:00 time points at both Eligibility Visits 1 and 2.The same eye(s) must qualify at all qualifying time points at both Eligibility Visits 1 and 2. The mean IOP is the average of IOP measurements in the same eye.

Patients must be able to discontinue use of all IOP-lowering medication(s) for a minimum period of 5 days to 28 days prior to Eligibility Visit 1.

Patients must be on a stable dosing regimen of medications affecting IOP for at least 30 days prior to the Screening Visit and must not change the dosing regimen during the eligibility period

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study

Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudo-exfoliation component) or confirmed ocular hypertension.

Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscopy.

Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.

Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of = 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.

History of, or current chronic, recurrent, or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.

History of ocular trauma within the past 6 months.

Intraocular surgery within the past 6 months.

Ocular laser surgery within the past 3 months.

Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal or 0.6 logMAR)

Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients’ history and/or examination.

History of, or current clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.

Any corneal abnormality preventing reliable applanation tonometry.

History of, or current severe, unstable or uncontrolled cardiovascular, hepatic or renal disease (e.g. sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension) that would preclude the safe administration of a topical beta-blocker.

History of, or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.

History of, or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.

History of severe or serious hypersensitivity to prostaglandin analogues, to CAIs, to beta-blockers or to any components of the study medications

Patients likely to use additional topical or systemic ocular hypotensive medication during the study.

Patients who cannot safely discontinue all glucocorticoid medications administered by any route.

Recent (within 4 weeks of Eligibility 1 Visit) use of high dose (> 1 gram daily) salicylate therapy.

History of uncontrolled diabetes or hypoglycemic episodes.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the IOP-lowering efficacy and the safety over 12 months, of morning or evening instillations of Travoprost / Brinzolamide versus COSOPT dosed in the morning and evening, in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: ;Primary end point(s): The primary efficacy parameter (end point) is mean IOP at the 9:00, 11:00 and 16:00 time points at Month 12.