Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery

• Conditions: Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery; MedDRA version: 9.1Level: PTClassification code 10064736Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-006228-36-FR
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified