Patients with Open-Angle Glaucoma or ocular hypertension MedDRA version: 23.1 Level: LLT Classification code 10084293 Term: Unilateral glaucoma System Organ Class: 100000004853
Conditions
Interventions
Product Name: Latanoprost 50 microgrammi/ml
Product Code: [2021-005170-25]
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: LATANOPROST
CAS Number: 130209-82-4
Current Sponsor code: 2021-
Sponsors
Genetic S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must meet all the following criteria to be eligible to participate in the study: 1 Adult patients (age =18 years). 2 Patients with unilateral or bilateral POAG or OH with IOP> 21 mm Hg. • Group A) Patients who are naïve (never received any IOP-lowering medications) or • Group B) * Patients have: an inadequate response to, loss of response to, or are intolerant or responder in accordance to medical judgement to other IOP lowering agents (including Alpha adrenergic, Beta-blockers, Atropine, Inhibitor of Carbonic Anhydrase or combined medications). • Group C) *Patients who are taking Prostaglandin and or Prostaglandin Analogues 3 Patients have given written informed consent approved by the Ethical Review Board (ERB). *Patients in Group B and C who are taking other medications will be randomized to begin the study treatment after a washout phase, as follows: A) Anticholinesterase agent (indirect acting): O a1-adrenergic antagonists: washout 4 weeks O ß-Adrenergic antagonists (ß-blockers plain and fixed combination,): washout 4 weeks B) Hyperosmotic Agent: O Parasympathomimetic agent washout 4 days O Prostaglandin Analogs (plain and fixed combination) washout 4 weeks C) Carbonic Anhydrase inhibitor: O Carbonic Anhydrase inhibitor: washout 7 days During the washout phase, all patients will receive a Carbonic Anhydrase inhibitor, which will be stopped one week before randomization. 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria will be excluded from participating in the study: Ocular Conditions 1. Visual acuity of 20/200 or worse in one or two eyes. 2. Clinically significant or progressive retinal disease (e.g., degenerations, diabetic retinopathy, retinal detachment). 3. Severe OAG (MD higher than -12 dB in the worst eye) 4. Any laser or ocular surgery within 3 months prior screening 5. Hypersensitivity to prostagland.in analogues or ingredients of the study products (latanoprost, benzalkonium chloride) 6. Use of contact lenses 7. Closed anterior chamber angle or angle-closure glaucoma 8. Any ocular filtering procedure General Exclusions 9. Female patients: Pregnant, lactating or planning pregnancy within next 12 months. (Female of child-bearing potential will undergo pregnancy test; they will be required use two reliable contraceptive methods during the study - hormonal methods such as pill and condom) 10. Subject is currently participating in another investigational drug or device clinical trial that may interfere with the results of either trial. 11. Subjects legally or mentally incapacitated unable to give their informed consent for their participation in this study. 12. Vulnerable patients 13. Subjects who are unable or unwilling to comply with the appointments or with all the requirements of the Protocol. Medical Conditions 14. History of any chronic-neurodegenerative disease. 15. Inflammatory or infectious disease, active at the time of study entry. 16. Injuries or traumatisms not resolved at the time of admission to the study. 17. Positive substance abuse (illegal drugs). 18. Any condition that in the opinion of the investigator makes the patients unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate of the non-inferiority of preservative-free Latanoprost (Genetic Spa) as compared with Xalatan (Pfizer) in decreasing mean IOP (evaluated with Goldmann applanation tonometry) in subjects with POAG or OH after treatment for 6 months.;Secondary Objective: The secondary objectives are the following: • to compare efficacy (mean IOP reduction) at months 1, and 3 months vs baseline. • to compare tolerability (assessed by V-14OSDI and OSDI) at month 1, 3 and 6 • to evaluate safety in patients treated with the study drug and comparator throughout the study follow-up period, with clinical assessments at 1, 3 and 6 months.;Primary end point(s): Evaluate of the non-inferiority of preservative-free Latanoprost (Genetic Spa) as compared with Xalatan (Pfizer) in decreasing mean IOP (evaluated with Goldmann applanation tonometry) in subjects with POAG or OH after treatment for 6 months.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Germany, Italy
Contacts
Public ContactR&D Manager
Genetic Spa
Outcome results
None listed