Condition category
Surgery
Date applied
26/11/2009
Date assigned
01/12/2009
Last edited
09/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pierre-Yves Robert

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Laboratoires Thea (France)

Sponsor details

12 rue Louis Blériot
Clermont-Ferrand
63017
France

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes