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: generic latanoprost 0.5 mg/mL, preservative free
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Latanoprost
CAS Number: 130209-82-4
Other descriptive name: LATANOPROST
Con
Sponsors
Polpharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA A patient is eligible for inclusion in this study if all of the following criteria apply. 5.2.1.1 Inclusion Criteria 1. Male or female patients, 18-75 years old. 2. Provision of signed and dated Informed Consent. 3. General health conditions not interfering with participation in the study e.g. blood pressure, pulse rate at screening as assessed by the investigator. 4. A female patient meeting one of the following criteria: 4.1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first study drug administration through to at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following: ? Abstinence from heterosexual intercourse; ? Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); ? Intrauterine device (IUD) (with or without hormones); ? Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository); ? Male partner vasectomized at least 6 months prior to the first study drug administration; Or 4.2. Participant whose partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable method of contraception from the first study drug administration through to at least 30 days after the last dose of the study drug. Or 4.3. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses prior to the first study drug administration). 5. Ocular hypertension or primary open angle glaucoma in at least one eye: mean diurnal IOP measured at -12, -8, –4, 0 hours pre-treatment on Day 1 must be higher than or equal to 22 mmHg, and lower than or equal to 34 mmHg (naïve or untreated, i.e. after washout). The eye with the higher IOP will be selected as the study eye. If both eyes have the same IOP, the right eye will be selected. 6. 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. 7. No ocular trauma, surgery, inflammation or infection, no corneal foreign body in the previous 3 months. 8. No clinically significant or progressive retinal disease as determined by dilated peripheral retinal examination done at screening. 9. No concomitant use of any topical ophthalmic medication other than artificial tears. 10. No ocular glucocorticoids in the previous 3 months. 11. Within the previous 30 days prior to the first dose (visit 1) no systemic medication that may alter IOP (e.g. beta blockers, calcium channel blockers, ACE inhibitors, prostaglandins, etc.) unless the current treatment with these medicinal products continues on a stable regimen for the duration of the study. 12. Patients may be contact lens wearers but must remove their contact lenses prior to each drug application and keep them removed for a minimum of 15 minutes after drug application. In addition, contact lenses must remain removed for a minimum of 20 minutes when ocular discomfort assessments are required. Contact lenses cannot be worn on the days of visits to the clinic. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years)
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Corrected visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20 or logMAR 0.70 in both eyes. 2. Evidence of acute ocular infection, corneal foreign body, or ocular inflammation within 3 months of the screening visit. 3. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis, iritis) in one or both eyes 4. Previous significant ocular trauma, laser or incisional surgery within 3 months of the screening visit including cataract surgery. 5. Traumatic cataract surgery with an open posterior capsule or any patient with an anterior chamber intraocular lens implant or aphakia 6. IOP in either eye greater than 34 mmHg at Day 1 (mean diurnal IOP measured at -12, -8, – 4, 0 hours pre-treatment) 7. Any corneal abnormalities preventing reliable applanation tonometry. 8. Patients at risk of angle closure or evidence of acute, intermittent or chronic angle closure. 9. Patients with forms of glaucoma resulting from conditions other than primary open angle glaucoma, such as pigmentary or pseudo-exfoliative glaucoma, open angle glaucoma of pseudophakic patients, neovascular glaucoma. 10. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination. 11. History or evidence of Herpes simplex keratitis. 12. Patients with known risk factors for macular edema. 13. Pregnant or nursing women or women who intend to become pregnant during the trial. 14. Patients who have participated in another research study for an investigational product or investigational medical device within 30 days of the screening visit. 15. History of drug or alcohol abuse within the last 6 months. 16. A history of hypersensitivity to latanoprost, or any component in the formulation of the products being tested. 17. History of evidence of any medical condition that would, in the opinion of the investigator, make the patient unsuitable for the study (i.e. severe hepatic, cardiovascular or renal impairment). 18. Systemic medication that may alter IOP in the previous 30 days (i.e. beta-blockers, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, prostaglandins etc.) if the treatment regimen with these medicinal products is change during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY OBJECTIVE The primary objective of this study is to evaluate the efficacy and tolerability of Latanoprost Polpharma (test product) in lowering of IOP when compared to the originator Xalatan® (reference product).;Secondary Objective: SECONDARY OBJECTIVES The secondary objectives of this study are: ? To compare the ocular tolerance of the test and reference products using an ocular comfort level score. ? To compare the levels of conjunctival hyperemia 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 newly developed delivery device (newly developed dropper bottle) in a subgroup of the patients.;Primary end point(s): PRIMARY ENDPOINT Non-inferiority of test product when compared with reference product, with respect to the differences in the mean diurnal IOP in the study eye at baseline (measured at -12, -8, -4 and 0 hours before treatment) on Day 1 and Day 29 (12, 16, 20 and 24 hours after treatment the previous day). 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 • Ocular Tolerance o Difference between the investigational products with respect to ocular comfort level score at baseline (Day 1) and Day 29. o Difference between the investigational products with respect to conjunctival hyperemia at baseline (Day 1) and Day 29. • Safety o Difference between the investigational products with respect to general safety as assessed by vital signs and the incidence and nature of adverse events. • Usability o Evaluation if usability of each of the delivery devices by the patients.;Timepoint(s) of evaluation of this end point: Day 1 vs Day 29 | — |
Countries
Hungary, Russian Federation
Contacts
Public ContactEva Szucs
Appletree CIG-AG
Outcome results
None listed