Patients for which cataract surgery has been planned. MedDRA version: 20.0 Level: PT Classification code 10007739 Term: Cataract System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: -
Product Code: [-]
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: LEVOFLOXACINA
CAS Number: 100986-85-4
Current Sponsor code: LEVOFLOXACINA
Concentration unit: mg/ml mill
Sponsors
NTC SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Male or female patients, aged =40 years 3. Patient undergoing phacoemulsification 4. Corneal thickness between 450 µm and 600 µm as measured by means of pachymetry 5. Corneal integrity confirmed by means of fluorescein test (Oxford scheme grade 0) 6. Adequate pupil dilation assessed at screening 7. Female patients of childbearing potential must have a negative pregnancy test 8. Ability to fully understand all study procedures 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 90
Exclusion criteria
Exclusion criteria: 1. Corneal epithelium integrity not confirmed by fluorescein test 2. History of corneal disease or dystrophy (e.g. ocular herpes, conjunctivitis, keratitis) 3. History of ocular trauma with corneal damage 4. History of acute ocular inflammation (including uveitis) in the 6 months prior to screening 5. Previous ocular surgery (including laser treatment) 6. Glaucoma 7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening 8. Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic (oxybuprocaine hydrochloride - Novesina®) followed by povidone-iodine (Oftasteril®) within 10 minutes before start of surgery 9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery (artificial tears without BAK are allowed) 10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery 11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone 12. Pregnant or lactating women 13. Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, whichever is longer, or who have previously participated in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the penetration of levofloxacin/dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.;Secondary Objective: -;Primary end point(s): Aqueous humour concentration of levofloxacin, dexamethasone 21-phosphate and dexamethasone.;Timepoint(s) of evaluation of this end point: After limbal paracentesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed