Open angle glaucoma or ocular hypertension. MedDRA version: 17.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Preservative-free Travoprost 40 µg/ml Eye Drops
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: TRAVOPROST
CAS Number: 157283-68-6
Concentration unit: µg/ml microgram(s)/mi
Sponsors
OmniVision GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be included, subjects will have to meet all of the following criteria: -male or female, of any race and =18 years of age; -diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension; -IOP =21 mmHg measured as the mean of two measurements in each eye; -on treatment for open-angle glaucoma with IOP-lowering drugs for at least 24 weeks (and the last 4 weeks with TRAVATAN® 40µg/ml), or treated with TRAVATAN® 40µg/ml for ocular hypertension for the last four weeks; -best-corrected visual acuity =20 of 100 corresponding to logMAR of 0.7 at both eyes; -in case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control measures; -expected by the investigator that IOP will remain controlled with the new treatment without optic nerve damage or progression of visual field loss; -able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits; -willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: In order to be included, subjects will have to meet none of the following criteria: -history of chronic or recurrent inflammatory eye disease, ocular trauma or infections; -history of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema -narrow-angle/angle-closure glaucoma; -corneal abnormalities that will preclude accurate IOP reading with an aplanation tonometer -clinically significant or progressive retinal disease; -intraocular surgery within the past 6 months; -ocular laser surgery within the past 3 months; -best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8; -current use of topical, ocular, nonsteroidal anti-inflammatory drugs -treatment with local or systemic corticosteroids; -not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine); -a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial ; -pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control; -current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s); -unwillingness or inability to comply with the clinical trial procedures; -unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; -who are legally incapacitated; -who are legally detained in an official institute Patients requiring bilateral IOP-reducing therapy are treated in both eyes, but only the eye(s) that fulfil(s) all of the inclusion criteria and none of the exclusion criteria are designated as clinical trial eye(s). An eye not meeting all inclusion criteria but having none of the exclusion criteria may be treated with the clinical trial drug at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to demonstrate the non-inferiority of the generic investigational medicinal product containing preservative-free Travoprost 40µg/ml in comparison with the commercially available preservative-containing comparator TRAVATAN® 40µg/ml (Alcon Laboratories Ltd UK) in the treatment of open angle glaucoma or ocular hypertension by examining the average change of diurnal IOP measured between last visit and baseline. ;Secondary Objective: Secondary efficacy objectives are the average change of diurnal IOP measured between baseline and weeks 1 and 2.and the proportion of patients with measured IOP <21 mmHg at the end of follow-up. ;Primary end point(s): Average diurnal IOP change from end of follow-up to baseline;Timepoint(s) of evaluation of this end point: At week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Average diurnal IOP change from weeks 1 and 2 to baseline. -Proportion of patients that kept the IOP less than IOP <21 mmHg at the end of follow-up. -Proportion of patients discontinuated for reasons related to treatment. ;Timepoint(s) of evaluation of this end point: At weeks 1, 2 , baseline and 4 week | — |
Countries
Greece
Contacts
Public ContactCLINICAL TRIAL INFORMATION
BECRO
Outcome results
None listed