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

ISRCTN ISRCTN41154297
DOI https://doi.org/10.1186/ISRCTN41154297
Clinical Trials Information System (CTIS) 2007-006228-36
Protocol serial number LT1225-PII-03/06
Sponsor Laboratoires Thea (France)
Funder Laboratoires Thea (France)
Submission date
26/11/2009
Registration date
01/12/2009
Last edited
09/08/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Pierre-Yves Robert
Scientific

Service d'Ophtalmologie
Hôpital Universitaire Dupuytren
2, avenue Martin Luther King
Limoges
87042
France

Study information

Primary study designInterventional
Study designPilot Phase II multicentre international randomised double-blind (for two groups G1 and G3) placebo-controlled trial
Secondary study designRandomised controlled trial
Scientific titleEfficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery: a pilot phase II randomised controlled trial
Study objectivesThis pilot clinical study aims to evaluate the 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.
Ethics approval(s)1. Committee for Protection of Research Subjects (Comité de Protection des Personnes [CPP]), Sud Ouest et Outre Mer 4 approved on 18/01/2008
2. Institutional Review Board (IRB), Vissum Intitute of Ophthalmology, Alicante (Vissum-Instituto de Oftalmológico de Alicante) approved on 15/01/2008
Health condition(s) or problem(s) studiedCataract surgery
InterventionTest 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.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Proportion of positive cultures on the day of surgery in the three study groups.

Key secondary outcome measure(s)

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.

Completion date25/05/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration75
Key inclusion criteria1. 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)
Key exclusion criteriaPatients 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.
Date of first enrolment22/04/2008
Date of final enrolment25/05/2009

Locations

Countries of recruitment

  • France
  • Spain

Study participating centre

Service d'Ophtalmologie
Limoges
87042
France

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan
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