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

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2009-010834-23-BE
• Date of registration: 27/04/2009
• Prospective Registration: Yes
• Primary sponsor: Alcon Research, Ltd.
• Public title: A multi-center, double-masked study of the safety and efficacy of DuoTrav APS compared to DuoTrav in patients with open-angle glaucoma or ocular hypertension - Safety and Efficacy of DuoTrav APS versus DuoTrav
• Scientific title: A multi-center, double-masked study of the safety and efficacy of DuoTrav APS compared to DuoTrav in patients with open-angle glaucoma or ocular hypertension - Safety and Efficacy of DuoTrav APS versus DuoTrav
• Date of first enrolment: 30/04/2009
• Target sample size: 330
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010834-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients of either sex and any race ,of 18 years of age or older.
- Patients diagnosed with open-angle glaucoma (with or without pseudoexfoliation or
pigment dispersion component) or confirmed ocular hypertension who would benefit
from a fixed combination medication, in the opinion of the Investigator.
- Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering medication.
- 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, as described in Section 9.4.7.
The same eye(s) must qualify at all qualifying time points.
- 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:
- Pregnancy or females of childbearing potential not taking adeqaute birth control measures
- Any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension
- Iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscoy
- Cup/Disc ratio greater than 0.80 (horizontal or vertical) in either eye
- Severe central visual field loss in either eye
- 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 (equivalent to
approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal)
- 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.
- 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.
- Any abnormality preventing reliable applanation tonometry.
- 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 or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent.
- 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-adrenergic blocking agent.
- History of spontaneous or current hypoglycemia or uncontrolled diabetes.
- History of or current severe allergic rhinitis and bronchial hyper reactivity.
- History of or current corneal dystrophies.
- History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, beta-adrenergic blocking agents, or to any components of the study medications.
- Patients who are unable, in the opinion of the Investigator, to safely discontinue use of all IOP-lowering medication(s) during the washout period.
- 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.
Note: Patients must be on a stable dosing regimen of these medications for at least 30 days prior to the Screening Visit and must not change the dosing regimen during the eligibility period with the exception of a substitution of the patient’s current ocular hypotensive medication for one requiring a shorter washout period.
Note: Patients using non-prescription and/or prescription topical ophthalmic
medications that do not affect IOP may be included in the study.
- Use of any additional topical or systemic ocular hypotensive medication during the
study.
- Patients wh

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension
MedDRA version: 9.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension

Intervention(s)

Product Name: DuoTrav APS
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: TRAVOPROST
CAS Number: 157283-68-6
Current Sponsor code: AL-6221
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: TIMOLOL MALEATE
CAS Number: 26921175
Current Sponsor code: AL-1239
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.8-(5 mg/ml timolol)

Trade Name: DuoTrav
Pharmaceutical Form: Eye drops, solution

Primary Outcome(s)

Primary end point(s): Mean IOP at 9.00, 11.00 and 16.00 time points at Month 3

Secondary Objective:

Main Objective: The primary objective of this study is to compare the
efficacy and safety of DuoTrav APS to DuoTrav, both
dosed once-daily in the morning, in patients with open angle
glaucoma or ocular hypertension.

Secondary ID(s)

C-09-006