Prevention and treatment of inflammation and prevention of infection associated with cataract surgery MedDRA version: 20.0 Level: PT Classification code 10007739 Term: Cataract System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: NA
Product Code: [NA]
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: LEVOFLOXACINA
CAS Number: 100986-85-4
Current Sponsor code: LEVOFLOXACINA
Concentration unit: mg/ml mi
Sponsors
NTC SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent must be obtained before any assessment is performed 2. Male or female, age =40 years 3. Senile or presenile uncomplicated cataract surgery 4. Willing to interrupt the use of contact lenses for the entire duration of the study 5. Able and willing to follow study procedures 6. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception, which include an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide. 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: 1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations (e.g. ocular herpes, blepharitis, conjunctivitis, uveitis, keratitis, diabetic retinopathy, retinal vein occlusions, retinal vasculitis, retinal angiomatous proliferation, pseudoexfoliation syndrome, intraoperative floppy iris syndrome, etc.) 2. Patients undergoing bilateral cataract surgery 3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-VEGF (vascular endothelial growth factor) drugs 4. Systemic diseases that may interfere with the results of the study (e.g. rheumatoid arthritis, Sjögren's syndrome, Behçet's disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.) 5. Any condition that could interfere with correct instillation of eye drops 6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening 7. Monocular patients 8. Visual Acuity (VA) < 20/80 in the contralateral eye 9. Contraindication to ocular treatment with levofloxacin, tobramycin or dexamethasone 10. Hypersensitivity to the study product or its excipients 11. Participation in other studies in the last month before screening 12. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The proportion of patients without signs of anterior chamber inflammation (sum of cells and flare score = 0).;Timepoint(s) of evaluation of this end point: After 14 days of treatment.;Main Objective: Efficay: To demonstrate the non-inferiority of combined levofloxacin + dexamethasone eye drops for 7 days followed by dexamethasone eye drops alone for an additional 7 days vs. standard treatment tobramycin + dexamethasone eye drops for 14 days in the prevention and treatment of postoperative ocular inflammation and prevention of infection.;Secondary Objective: - Safety and tolerability: To evaluate the safety of combined levofloxacin - dexamethasone eye drops; To evaluate the tolerability of combined levofloxacin - dexamethasone eye drops. - Compliance: To evaluate compliance with prescribed treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Incidence of endophthalmitis - Proportion of patients without signs of anterior ocular chamber inflammation - Conjunctival hyperemia - Total Ocular Symptoms Score (TOSS) - Ocular pain/discomfort - Use of rescue therapy; Safety and tolerability: - Intraocular pressure (IOP) - Visual acuity (ETDRS) - Adverse events - Global evaluation - Burning, stinging, blurred vision; Compliance: - Assessment of patient diary;Timepoint(s) of evaluation of this end point: Efficacy: - During treatment - After 3 and 7 days of treatment - After 3, 7 and 14 days of treatment - After 3, 7 and 14 days of treatment - After 3, 7 and 14 days of treatment - During treatment; Safety and tolerability: - After 3, 7 and 14 days of treatment - After 14 days of treatment - During treatment - After 3, 7 and 14 days of treatment - After 3, 7 and 14 days of treatment; Compliance: - After 3, 7 and 14 days of treatment | — |
Countries
Germany, Italy, Russian Federation, Spain
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed