Open angle glaucoma or ocular hypertension. MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders MedDRA version
Conditions
Interventions
Product Name: Latanoprost/Timolol (50µg+5mg)ml
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Latanoprost
CAS Number: 130209-82-4
Sponsors
PHARMATHEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.male or female, of any race and =18 years of age; 2.diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension; 3.average IOP = 22 mmHg and = 35 mmHg measured at 08:00, 12:00 and 16:00 hours pre-treatment in at least one eye at day 0; 4.non-efficiently controlled IOP when treated either with prostaglandin analogues or b-blockers as monotherapy , according to investigator, at least 4 weeks before trial inclusion; 5.without treatment for open-angle glaucoma with IOP-lowering drugs for at least 4 weeks; 6.best-corrected visual acuity =20 of 100 (Snellen) corresponding to logMAR of 0.7; 7.no new systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on stable regimen for 30 days prior to the study and during the study; 8.patients with controlled arterial blood pressure according to the investigator’s opinion; 9.in case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control measures; 10.expected by the Investigator that IOP will remain controlled with the new treatment without optic nerve damage or progression of visual field loss; 11.able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits; 12.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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: 1.history of chronic or recurrent inflammatory eye disease, ocular trauma or infections; 2.history of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema; 3.narrow-angle glaucoma, angle-closure glaucoma; 4.compromised cornea or corneal abnormalities that will preclude accurate IOP reading with an aplanation tonometer; 5.clinically significant or progressive retinal disease; 6.intraocular surgery within the past 3 months; 7.ocular laser surgery within the past 1 months; 8.best-corrected visual acuity = 20 of 100 (Snellen), corresponding to worse than 0.7 logarithm of minimal angle of resolution (logMAR) score; 9. cup/disk ratio >0.8; 10. current use of topical, ocular, nonsteroidal anti-inflammatory drugs; 11. history of reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease; 12.history of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, cardiogenic shock; 13.treatment with local or systemic corticosteroids; 14.ocular treatment with any prostamide, prostaglandin, alpha- adrenergic receptor agonist, ß-adrenergic blocker and pilocarpine; 15.any change in any systemic medication that affects IOP within the last 30 days (e.g. clonidine); 16.treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide); 17.history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial; 18.history of severe or unstable and uncontrolled cardiovascular disease; 19.pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control; 20.current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s); 21.unwillingness or inability to comply with the clinical trial procedures; 22.unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; 23.who are legally incapacitated; 24.who are legally detained in an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the clinical non-inferiority of a generic ophthalmic product of Latanoprost 50µg/ml/Timolol 5mg/ml fixed combination which is preservative-free (test) compared with the marketed preservative-containing Xalacom® (reference) eye drops in patients with open angle glaucoma or ocular hypertension by examining the change of IOP at 8:00am from end of study to baseline.;Secondary Objective: The secondary objectives are i) to compare the efficacy of the two latanoprost/timolol products (test and reference) in terms of IOP and ii) to compare their tolerability. ;Primary end point(s): Change in IOP at 8:00am in study eye from end of treatment (week 12) to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product.;Timepoint(s) of evaluation of this end point: At week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in IOP at 12:00pm and 16:00pm in study eye from end of treatment (week 12) to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product. -Change in IOP at 8:00am, 12:00pm and 16:00pm in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product. -Change in IOP at 8:00am, 12:00pm and 16:00pm in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product. Safety: -Ocular and systemic AEs -Clinically significant safety findings at ocular examination. -Decrease in visual acuity as compared to baseline (Week 0). ;Timepoint(s) of evaluation of this end point: ?t 2,6,12 week | — |
Countries
Greece
Contacts
Public ContactCLINICAL TRIAL INFORMATION
BECRO
Outcome results
None listed