Profilaxis Antibiótica Perioperatoria (descontaminación de la superficie ocular) MedDRA version: 9.1 Level: PT Classification code 10064736 Term:
Conditions
Interventions
Trade Name: Azithromycin dihydrate
Product Name: AZYTER
Product Code: T1225 1.5%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Azithromycin dihydrate
CAS Number: 83905-01-5
Current Spo
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed and dated informed consent. -Male or female aged from 18 to 80 years old. -Uncomplicated cataract. -Scheduled to undergo cataract surgery (phacoemulsification – foldable intra-ocular lens surgery with injector – clear corneal incision). 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: Surgical conditions in the eye to be operated: -Combined surgery. -Other cataract aetiologies than senile or pre-senile cataract. Non-surgical conditions in the eye to be operated: -Dacryocystitis and all others pathologies of tears drainage system. -Inflammatory ocular disease (uveitis, herpetic keratitis). -Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis). -History of ocular traumatism, infection or inflammation within the last 3 months. Ophthalmic condition in the contra lateral eye: -Best corrected visual acuity < 1/10. -Patient already included in the study for phakoexeresis. -History of surgical complication (notably endophthalmitis) Ophthalmic condition in either eye: -Presence of glaucoma and/or ocular hypertension history, -Presence of any other ocular pathology such as dry-eye syndrome, allergy in either eye likely to require a topical treatment from Day-15 to Day 5 conjunctival sampling. Systemic/non ophthalmic conditions None of the following criteria: General history: -Diabetes not controlled, Infectious diseases, Immunosuppressive diseases, -Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc... and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study. Allergic history: -Known hypersensitivity to one of the components of the study medications or to any other macrolide antibiotic or to test products, -Allergic rhinitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate efficacy and safety of Azyter® (T1225 1.5%) versus control groups in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery in combination of povidone iodine application and intracamerular injection with cefuroxime.;Secondary Objective: Proportion of positive cultures the day of surgery depending on the sampling site : occurance of positive cultures: - on Day 0, in conjunctival cul de sac of the eye to be operated - on Day 0, in lid margin of the eye to be operated Proportion of positive cultures at Day 5 after surgery: Occurrence of a positive culture on Day 5 -either in conjunctival cul de sac or/and in lid margin of the operated eye. -in the conjunctival cul de sac of the operated eye. -in the lid margin of the operated eye. Numeration of germ and of species, on Day -2, Day 0 and Day 5. For each positive culture at Day-2, Day 0 and Day 5, the numeration will be performed for each germ (in colony forming units) and for each species. ;Primary end point(s): the primary endpoint will be the proportion of positive cultures on the day of surgery in the three study groups either in the conjunctival cul de sac or in the lid margin of the eye to be operated. A culture is defined as positive when there is at least one germ identified. | — |
Countries
France, Spain
Outcome results
None listed