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 |
| EudraCT/CTIS number | 2007-006228-36 |
| Secondary identifying numbers | LT1225-PII-03/06 |
- 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
Scientific
Service d'Ophtalmologie
Hôpital Universitaire Dupuytren
2, avenue Martin Luther King
Limoges
87042
France
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 22/04/2008 |
| Completion date | 25/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 75 evaluable patients |
| Key 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) |
| Key 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. |
| Date of first enrolment | 22/04/2008 |
| Date of final enrolment | 25/05/2009 |
Locations
Countries of recruitment
- France
- Spain
Study participating centre
Service d'Ophtalmologie
Limoges
87042
France
87042
France
Sponsor information
Laboratoires Thea (France)
Industry
Industry
12 rue Louis Blériot
Clermont-Ferrand
63017
France
"ROR" |
https://ror.org/04edz9p52 |
|---|
Funders
Funder type
Industry
Laboratoires Thea (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
