Open Angle Glaucoma or Ocular Hypertension MedDRA version: 18.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Travoprost+Timolol
Pharmaceutical Form: Eye drops
INN or Proposed INN: TIMOLOL MALEATE
CAS Number: 26921-17-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
OMNIVISION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? male or female patients, of any race and ?18 years of age; ? diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension; ? on treatment with an IOP-lowering prostaglandin analogue/beta blocker combination for at least 6 months; ? on treatment with an IOP ?21 mmHg on medication measured as a mean of both eyes at two measurements at least one hour apart; ? best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes; ? in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures; ? expected by the investigator that IOP would 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 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: ? pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogue/beta blocker combinations; ? a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections; ? narrow-angle/angle-closure glaucoma; ? clinically significant or progressive retinal disease; ? intraocular surgery within the past 6 months; ? ocular laser surgery within the past 3 months; ? a change in glaucoma therapy within 1 month before the screening visit; ? 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; ? history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease. ? treatment with local or systemic corticosteroids; ? inability to discontinue the use of glucocorticoid medications; ? 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 or a contraindication of ß-adrenergic receptor antagonists due to systemic disease; ? sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock ? 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 and saving and transmission of pseudonymous medical data for clinical trial reasons; ? who are legally incapacitated, ? who are legally detained in an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to demonstrate the non-inferiority of the investigational medicinal product containing the preservative-free combination of Travoprost (40 µg/ml), Timolol (5 µg/ml) in comparison with the commercially available preservative-containing comparator Travoprost/Timolol (DuoTrav?, Alcon Laboratories Ltd., UK) in the treatment of primary open angle glaucoma or ocular hypertension by the average decrease of diurnal IOP measured between baseline and last visit.;Secondary Objective: Secondary efficacy objectives are the average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial.;Primary end point(s): To demonstrate the non-inferiority of the investigational medicinal product containing the preservative-free combination of Travoprost (40 µg/ml), Timolol (5 µg/ml) in comparison with the commercially available preservative-containing comparator Travoprost/Timolol (DuoTrav?, Alcon Laboratories Ltd., UK) in the treatment of primary open angle glaucoma or ocular hypertension by the average decrease of diurnal IOP measured between baseline and last visit.;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial.;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Spain
Contacts
Public ContactMiriam Hoffmann
OMNIVISION
Outcome results
None listed