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 - Safety and Efficacy of Travoprost APS versus TRAVATAN®

Phase 1

• 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: EUCTR2008-002760-34-DE
• Lead Sponsor: Alcon Research, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-01
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

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 confirmed ocular hypertension. Diagnosis of ocular hypertension in treatment-naïve patients should be documented as elevated IOP (e.g., = 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 4 weeks) 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:
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.
The mean IOP is the average of IOP measurements in the same eye
4.Only patients who satisfy all Informed Consent requirements may be included in the study.
5.Patients who wear contact lenses will be allowed to participate in the study provided that the contact lenses are removed before instillation of study medication, and that the patients wait a minimum of 15 minutes following drug instillation before re-inserting the lenses.
6.Patients must be able to discontinue use of any IOP-lowering medication for a minimum of 5 days to 28 days prior to Eligibility Visit 1 according to the ocular hypotensive medication washout schedule. The Investigator shall assess the minimum washout period based on the class of the current IOP-lowering medication taken by the patient.
7.Patients willing to complete all required study visits.

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

Pregnancy:
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.
Exclusion Criteria related to the disease being investigated:
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. 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.
Exclusion Criteria related to ocular/systemic patient history or current ocular condition 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 read (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.
Exclusion Criteria related to systemic or ocular medications:
15.History of severe or serious hypersensitivity to prostaglandin drugs or their analogues 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 APS.
16.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.
17.Use of any additional topical or systemic ocular hypotensive medication during the study.
18.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 Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study.
Others:
19.Patients who are current

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 both dosed once-daily in the evening, in patients with open-angle glaucoma or ocular hypertension;Secondary Objective: ;Primary end point(s): Mean IOP at Month 12 (9:00, 11:00 and 16:00 time points)