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ISRCTN
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ISRCTN41154297
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ClinicalTrials.gov identifier
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Public title
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Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery
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Scientific title
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Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery : A pilot phase II randomised controlled trial
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Acronym
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NA
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Serial number at source
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LT1225-PII-03/06
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Study hypothesis
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This pilot clinical study aims 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.
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Ethics approval
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1. Committee for Protection of Research Subjects (Comité de Protection des Personnes [CPP]), Sud Ouest et Outre Mer 4 approved on the 18th of January 2008 (Eudract N° 2007-006228-36)
2. Institutional Review Board (IRB), Vissum Intitute of Ophthalmology, Alicante (Vissum-Instituto de Oftalmológico de Alicante) approved on the 15th of January 2008 (Eudract N° 2007-006228-36)
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Study design
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Pilot Phase II multicentre international randomised double-blind (for 2 groups G1 and G3) placebo controlled trial
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Countries of recruitment
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France, Spain
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Disease/condition/study domain
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Cataract surgery
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Participants - inclusion criteria
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1. Signed and dated informed consent
2. Male or female aged from 18 to 80 years old
3. Uncomplicated cataract
4. Scheduled to undergo cataract surgery (phacoemulsification – foldable intra-ocular lens surgery with injector – clear corneal incision)
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Participants - exclusion criteria
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Patients with the following ophthalmic conditions will be excluded:
1. Surgical conditions in the eye to be operated:
1.1. Combined surgery.
1.2. Other cataract aetiologies than senile or pre-senile cataract.
2. Non-surgical conditions in the eye to be operated:
2.1. Dacryocystitis and all others pathologies of tears drainage system.
2.2. Inflammatory ocular disease (uveitis, herpetic keratitis).
2.3. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
2.4. History of ocular traumatism, infection or inflammation within the last 3 months.
3. Ophthalmic condition in the contra lateral eye:
3.1. Best corrected visual acuity < 1/10.
3.2. Patient already included in the study for phakoexeresis.
3.3. History of surgical complication (notably endophthalmitis)
4. Ophthalmic condition in either eye:
4.1. Presence of glaucoma and/or ocular hypertension history,
4.2. 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.
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Anticipated start date
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22/04/2008
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Anticipated end date
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25/05/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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75 evaluable patients
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Interventions
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Test product: T1225, Azithromycin 1.5%
Group 1 : T1225 1.5% eye drops for 1 day before surgery and for 2 days after surgery.
Group 2 : T1225 1.5% eye drops for 3 days after surgery.
Placebo: T1225, vehicle
Group 3 : Placebo eye drops for 1 day before surgery and for 2 days after surgery.
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Primary outcome measure(s)
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Proportion of positive cultures on the day of surgery in the three study groups.
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Secondary outcome measure(s)
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1. Proportion of positive cultures at endpoint (day of surgery) depending on the sampling site.
2. Proportion of positive cultures at Day 5 after surgery.
3. Numeration of germ and of species, on Day -2, Day 0 and Day 5.
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Sources of funding
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Laboratoires Thea (France)
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Trial website
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Publications
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Contact name
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Prof
Pierre-Yves
Robert
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Address
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Service d'Ophtalmologie
Hôpital Universitaire Dupuytren
2, avenue Martin Luther King
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City/town
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Limoges
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Zip/Postcode
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87042
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Country
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France
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Sponsor
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Laboratoires Thea (France)
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Address
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12 rue Louis Blériot
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City/town
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Clermont-Ferrand
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Zip/Postcode
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63017
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Country
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France
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Date applied
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26/11/2009
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Last edited
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01/12/2009
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Date ISRCTN assigned
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01/12/2009
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