Subjects affected by glaucoma or intraocular hypertension. MedDRA version: 9.1 Level: SOC Classification code 10015919
Conditions
Interventions
Product Name: prostaglandin analogues
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: prostaglandin analogues
CAS Number: 130209824
Current Sponsor code: Latanoprost PK
Concentration uni
Sponsors
PH&T SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult subjects of either sex, Subjects affected by unilateral or bilateral POAG or IOH, IOP > 21 mm Hg at Randomization visit, Subjects who have given written informed consent, consistent with local requirements. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects affected by closed or slit like anterior chamber angle, Positive history for acute angle closure, Positive history of argon laser trabeculoplasty within 3 months prior screening (the unlasered eye could be enrolled in the study) or of any ocular filtering surgical intervention (the unoperated eye could be enrolled in the study), Ocular surgery or ocular inflammation/infection in either eye within 3 months prior to screening, Current use of contact lenses, Best corrected visual acuity 3x the upper limit of normal range, Hypersensitivity to any of the components of the treatment medication, Female subjects of child-bearing potential with a positive pregnancy test; Female subjects who are nursing; Impossibility to attend all the planned visits and/or to have all the tests foreseen by the protocol performed, History of non-compliance, alcoholism or drug abuse, Subjects having previously participated in this study or in a clinical trial of an investigational drug within the last 30 days prior to the Screening visit, Subject has any condition which, in the opinion of the investigator, could interfere with the study results or be considered detrimental to the subject?s welfare.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to assess the therapeutic equivalence of two different formulation of Latanoprost (Latanoprost PK versus Xalatan) in the treatment of subjects affected by primary angle glaucoma (POAG) or ocular hypertension (OH) treated for 12 weeks.;Secondary Objective: To assess local tolerability of the two formulations, in terms of local adverse events, To assess systemic tolerability of the two formulations in terms of changes in vital parameters (arterial blood pressure and heart rate will be registered at each visit), onset of systemic adverse events (registered at each visit) and changes in laboratory parameters (assessed at the entry and at the end of the 12-week treatment), To calculate the percentage change in IOP from start to end of 12-week treatment, To calculate the reduction in IOP by both formulation, at each time point recorded at baseline and at the end of the 12-week treatment.;Primary end point(s): Primary end-point will be the change in IOP from baseline in 2 study groups at 12 weeks. | — |
Countries
Italy
Outcome results
None listed