GLAUCOMA, OCCULAR HYPERTENSION
Conditions
Interventions
Product Name: YSLT Latanoprost 50 µg/mL Eye Drop Solution
Pharmaceutical Form: Eye drops, solution in single-dose container
Trade Name: XALATAN
Product Name: Xalatan 50 micrograms/mL Eye drops, solut
Sponsors
YONSUNG GMBH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained from the subject or legal representative before any trial assessment. 2) Male or female, of any race and =18 years of age. 3) Diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension. 4) The IOP is between = 22 mm Hg and = 35 mm Hg in at least one eye at the time of screening (single measurement) and at baseline (average IOP measured at 09:00, 12:00 and 16:00 hours pre-treatment). 5) Without treatment for primary open-angle glaucoma or OHT with IOP-lowering drugs for at least 4 weeks (wash out period of 4 weeks) prior to baseline. 6) Best-corrected visual acuity =20 of 100 (Snellen) corresponding to logarithm of minimal angle of resolution (logMAR) score of 0.7. 7) No new systemic medication that may alter IOP (e.g., beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.) during the 30 days prior baseline. If the patient is currently treated with these medicinal products is expected to receive a stable regimen for 30 days prior to baseline that will be followed throughout the duration of the trial. 8) Subjects with controlled arterial blood pressure according to the judgment of the investigator. 9 Expected, as judged by the Investigator, that IOP will remain controlled with the IMP treatment without optic nerve damage or progression of visual field loss. 10) Able to understand the requirements of the clinical trial and to agree to participate in all trial visits. 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 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 102
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/angle-closure glaucoma. 4) Corneal abnormalities that will preclude accurate IOP reading with an applanation tonometer. 5) Clinically significant or progressive retinal disease. 6) Intraocular surgery within the 3 months before baseline. 7) Ocular laser surgery within one month before baseline. 8) Current use of topical, ocular, nonsteroidal anti-inflammatory drugs. 9) Treatment with local or systemic corticosteroids. 10) Treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide). 11) History of allergic hypersensitivity or poor tolerance to any component of the eye drop solution (IMP) used in this clinical trial. 12) Current participation or not yet completed period (at least 30 days since the ending) of other investigational device or drug trial(s). 13) Pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the clinical non-inferiority of the YSLT latanoprost 50µg/ml eye drops solution Yonsung GmbH (test product) in lowering intra-ocular pressure (IOP) in patients with POAG and OHT as compared to latanoprost 50µg/ml eye drops solution product Xalatan®, Pfizer (reference product).;Secondary Objective: •to assess the levels of conjunctival hyperaemia induced in the test and reference product, •to assess the efficacy of test vs reference product in IOP change after 4 weeks of treatment, •to assess the safety profile of treatments considered. ;Primary end point(s): Difference in mean change in the mean diurnal IOP from baseline to 12 Weeks of treatment between test and reference products as measured by a Goldmann Applanation Tonometer. The mean diurnal IOP (mmHg) of the study eye at baseline or at 12 Weeks is calculated as the average of 3 IOP measurements at 9 am (± 30 min), 12 pm (± 30 min) and 4 pm (± 30 min) taken at the visit day. ;Timepoint(s) of evaluation of this end point: 12 WEEK | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference in the mean change from Baseline of conjunctival hyperaemia levels (as described in section 7.7) between test and reference; Baseline to Week 4 and Week 12. • Difference in mean change from baseline in the mean diurnal IOP at Week 4, between test and reference products as measured by a Goldmann Applanation Tonometer. The mean diurnal IOP (mmHg) of the study eye is calculated as the average of 3 IOP measurements at 9 am (± 30 min), 12 pm (± 30 min) and 4 pm (± 30 min). • Incidence and severity of adverse events during treatment with test or reference products. ;Timepoint(s) of evaluation of this end point: 1) Baseline to Week 4 and Week 12. 2) week 4 3)during all study | — |
Countries
Greece
Contacts
Public ContactCLINICAL OPERATIONS
Pharmabide Ltd
Outcome results
None listed