Additional identifiers
EudraCT number
2007-006228-36
ClinicalTrials.gov number
Protocol/serial number
LT1225-PII-03/06
Study information
Scientific title
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
Acronym
Study hypothesis
This 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
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
Study design
Pilot Phase II multicentre international randomised double-blind (for two groups G1 and G3) placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cataract surgery
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Phase II
Drug names
Primary outcome measures
Proportion of positive cultures on the day of surgery in the three study groups.
Secondary outcome measures
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.
Overall trial start date
22/04/2008
Overall trial end date
25/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
75 evaluable patients
Participant exclusion criteria
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.
Recruitment start date
22/04/2008
Recruitment end date
25/05/2009
Locations
Countries of recruitment
France, Spain
Trial participating centre
Service d'Ophtalmologie
Limoges
87042
France
Funders
Funder type
Industry
Funder name
Laboratoires Thea (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary