Ocular hypertension and open angle glaucoma 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
Conditions
Interventions
Product Name: latanoprost + timolol (50 µg + 5 mg)/ml oldatos szemcsepp (Polpharma S.A.), preservative free
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Latanoprost and Timolol
CAS Nu
Sponsors
Pharmaceutical Works Polpharma S.A. (Polpharma S. A.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA • Ocular hypertension or primary open angle glaucoma in at least one eye: mean diurnal IOP measured on Day 1 before treatment at 8 am, 12 pm and 4 pm on the day must be higher than or equal to 22 mmHg, and lower than or equal to 34 mmHg (untreated, i.e. after washout). • Not on any ophthalmic pressure-lowering medication, or able to be withdrawn from current pressure-lowering medications for the washout periods as defined in this clinical trial protocol. • No clinically significant or progressive retinal disease. • No concomitant use of any topical ophthalmic medication other than artificial tears • No ocular glucocorticoids in the previous 3 months • No concomitant use of any medication that may increase adrenergic activity, i.e. psychotropic substances such as amitriptyline • No systemic medication that may alter IOP in the previous 30 days (e.g. beta blockers, calcium channel blockers, ACE inhibitors, prostaglandins, etc.) or expected to continue the current treatment with these medicinal products on a stable regimen for the duration of the study. Other inclusion criteria • Age: 18-85 years old • Provision of signed and dated Informed Consent. • General health conditions not interfering with participation in the study determined e.g. by blood pressure, pulse rate and temperature at screening as assessed by the Investigator • Female patients of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose and throughout the study or be using acceptable methods of birth control. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Exclusion Criteria • Corrected visual acuity of less than 20/100 in both eyes • Evidence of acute ocular infection, corneal foreign body, or ocular inflammation within 3 months of the screening visit. • History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis, iritis) in one or both eyes • Previous significant ocular trauma, laser or incisional surgery within 3 months of the screening visit • Traumatic cataract surgery with an open posterior capsule or any patient with an anterior chamber intraocular lens implant or aphakia • IOP in either eye exceeding 34 mmHg (mean diurnal IOP on Day 1 before treatment at 8 am, 12 pm and 4 pm). • Any corneal abnormalities preventing reliable applanation tonometry. • Patients at risk of angle closure or evidence of acute, intermittent or chronic angle closure • Forms of glaucoma resulting from conditions other than primary open-angle glaucoma or ocular hypertension, such as pigmentary or pseudo-exfoliative glaucoma., • Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination. • History or evidence of Herpes simplex keratitis. • Patients with known risk factors for macular oedema. • Patients suffering from reactive airway disease including bronchial asthma or with a history of bronchial asthma or severe chronic obstructive pulmonary disease. • Patients suffering from Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with a pacemaker, overt cardiac failure, or cardiogenic shock. • Patients, for which the absorption of the beta blocking agent, timolol, may in the Investigator’s opinion acerbate pre-existing systemic conditions, such as cardiac, vascular or respiratory disorders, hypoglycaemia or diabetes. • Hypersensitivity to the active substances or to any of the excipients of the test or reference products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY OBJECTIVE The primary objective is to evaluate the efficacy of the generic Latanoprost + Timolol (50µg + 5mg)/ml eye drops, solution (Polpharma S.A.; test product) in lowering IOP when compared to the originator Xalacom® (latanoprost 0.005% & timolol 0.5% fixed combination ophthalmic solution, Pfizer; reference product).;Secondary Objective: Secondary Objective(s) • To compare the ocular tolerance of the test and reference products using an ocular comfort level score. • To compare the levels of conjunctival hyperaemia induced by test product and reference product. • To evaluate safety in general determined by vital signs and the incidence and nature of AEs of the test product compared to the reference product. • To evaluate the usability of the test product delivery device by comparison with the reference product delivery device.;Primary end point(s): PRIMARY ENDPOINT Non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP in the study eye at baseline (measured at 8 am, 12 pm and 4 pm on the day before treatment initiation at 8 am the following day) on Day 1 and on Day 29 (before treatment at 8 am, and 4 and 8 hours after the first measurement. IOP will be assessed using the Goldmann applanation tonometry.;Timepoint(s) of evaluation of this end point: Day1 versus Day29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SECONDARY ENDPOINTS Efficacy Non-inferiority of the test product when compared to the reference product with respect to the differences in the mean IOP in the study eye at baseline for each of the three measurement time points before and after treatment. Ocular Tolerance • Difference between the investigational products with respect to ocular comfort level score at baseline (Day 1) and Day 29 • Difference between the investigational products with respect to conjunctival hyperaemia at baseline (Day 1) and Day 29. Safety • Difference between the investigational products with respect to general safety as assessed by vital signs and the incidence and nature of adverse events. Usability • Evaluation if usability of the test product delivery device by comparison with the reference product delivery device.;Timepoint(s) of evaluation of this end point: Day 1 vs Day 29 | — |
Countries
Hungary
Contacts
Public ContactEva Szucs
Appletree CIG-AG
Outcome results
None listed