Estudio multicéntrico, doble enmascarado, de tres meses para comparar la seguridad y eficacia de la combinación fija de Travoprost/Brinzolamida colirio en suspensión vs TRAVATAN vs AZOPT en pacientes con glaucoma de ángulo abierto o hipertensión ocular.A Three-Month, Multicenter, Double-Masked Study Comparing the Safety and Efficacyof the Fixed Combination Travoprost + Brinzolamide Eye Drops, Suspension vsTravatan vs Azopt in Patients with Open-Angle Glaucoma or ocular Hypertension - Travoprost / Brinzolamide Fixed Combination vs. TRAVATAN and vs. AZOPT

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: EUCTR2008-002780-13-ES

Lead Sponsor: Alcon Research, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. 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.
2. 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 during the Screening Visit. The same eye(s) must qualify at both time points.
3. 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 mean IOP in either eye at the Eligibility Visits 1 and 2 must not be greater
than 36 mmHg at any time point.
• The same eye(s) must qualify at all qualifying time points at both Eligibility Visits
1 and 2.
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

1. Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet any one of the following conditions:
- They are currently pregnant or,
- They have a positive result on the urine pregnancy test at the Screening Visit or,
- They intend to become pregnant during the study period or,
- They are breast-feeding or,
- They are not using highly effective birth control measures
2. Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.
3. Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy (see Section 18.1.4.).
4. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
5. 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 (see Section 9.4.5. for details on the procedure).
6. 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.
7. History of ocular trauma within the past 6 months.
8. Intraocular surgery within the past 6 months.
9. Ocular laser surgery within the past 3 months.
10. Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal) (see Section 9.4.8. for details on the procedure).
11. 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.
12. History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment.
13. Any abnormality preventing reliable applanation tonometry.
14. 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.
15. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, CAIs or to any components of the study medications. For listings of additional formulation components present in the study medications, see the Clinical Investigator’s Brochure for Travoprost / Brinzolamide which includes the Summary of Product Characteristics for TRAVATAN and AZOPT.
16. Less than 30 days on stable dosing regimen before the Screening Visit with any medications or substances administered by any route and used on a chronic basis that may affect IOP, including, but not limited to, beta-adrenergic blocking agents.
Note: 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. Any change in dosage or addition of such medication(s) during the study must be documented in the patient’s chart.
17. Use of any additional topical or systemic ocular hypotensive medication during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the IOP lowering efficacy of morning or evening instillations of<br>Travoprost / Brinzolamide, versus TRAVATAN dosed in the evening, versus AZOPT dosed in the morning and in the evening, in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: ;Primary end point(s): Primary Efficacy: Mean IOP<br>Key Secondary Efficacy: Mean Diurnal IOP<br>Secondary Efficacy: Percent change in IOP, IOP change from baseline, and number and percentage of patients with IOP <18 mmHg<br>Safety: Ocular Signs, Best-Corrected Visual Acuity, Fundus Parameters, Ocular Hyperemia, Adverse Event<br>

Secondary Outcome Measures