A multi-center, double-masked study of the safety and efficacy of Travoprost APS compared to TRAVATAN in patients with open-angle glaucoma or ocular hypertension. - Efficacy study of Travoprost APS versus TRAVATA

Conditions: Open-angle glaucoma or ocular hypertension
MedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucoma
MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension

Registration Number: EUCTR2008-006027-31-BE

Lead Sponsor: Alcon Research, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

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. Diagnosis of ocular hypertension in treatment-naïve patients should be documented as elevated IOP (i.e., =21 mmHg) at multiple points within the past year.
2. Patients not currently on any IOP-lowering medication or currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering monotherapy (not a fixed combination product) medication.
3.Patients must meet the following IOP entry criteria in at least one eye at Eligibility Visits 1 & 2:
•Mean IOP = 24 mmHg at the 09:00 time point, and
•Mean IOP = 21 mmHg at the 11:00 and 16:00 time points.
•The mean IOP in either eye at Screening or Eligibility must not be greater than 36 mmHg at any time point.
The mean IOP is the average of IOP measurements in the same eye.
The same eye(s) must qualify at all qualifying time points.
4. Only patients who satisfy all Informed Consent requirements may be included in the study.

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 pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
3.Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscopy.
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.
6.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.
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 (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
11.Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination.
12.History of, or current clinically relevant (in the opinion of the Investigator) 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 or to any components of the study medications.
16.Patients who are unwilling to remove their contact lenses prior to instillation of the study medication and to leave them out for a minimum of 15 minutes following instillation before reinserting the lenses for the duration of the study.
17.Patients who are unable, in the opinion of the Investigator, to safely discontinue use of all IOP-lowering medication(s) during the washout period.
18.Less than 30 days stable dosing regimen before the Screening Visit of 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.
19.Use of any additional topical or systemic ocular hypotensive medication during the study.
20.Patients who cannot safely discontinue all glucocorticoid medications administered by any route. Patients must have washed out of chronic glucocorticoid medications for at least 4 weeks, or of intermittent glucocorticoid medications for at least 2 weeks before the Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study.
21.Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit
22.Patients not willing to complete

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 efficacy and safety of Travoprost APS to TRAVATAN Solution, both dosed once-daily in the evening, in patients with open-angle glaucoma or ocular hypertension;Secondary Objective: ;Primary end point(s): Primary efficacy: Mean IOP<br>Safety: Adverse Events

Secondary Outcome Measures

Name	Time	Method

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