Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis - Full Text View

Sponsored by:	Laboratoires Thea
Information provided by:	Laboratoires Thea
ClinicalTrials.gov Identifier:	NCT00357773

Purpose

To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety

Condition	Intervention	Phase
Conjunctivitis, Bacterial	Drug: Azithromycin (T1225)	Phase III

MedlinePlus related topics: Pinkeye

Drug Information available for: Tobramycin Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Efficacy and Safety of T1225 1.5% Eye Drops (3-Day Treatment) Versus Tobramycin 0.3 % Eye Drops (7-Day Treatment) in the Treatment of Purulent Bacterial Conjunctivitis

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:

Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)

Secondary Outcome Measures:

Clinical cure at Day 3
Microbiological cure at Day 3 and Day 9
Global efficacy.
Tolerance

Study Start Date:	May 2004
Estimated Study Completion Date:	June 2005

Detailed Description:

The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female >= 1 day old (newborn, infant, child, adult);
written informed consent by patient or legally acceptable representative;
purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe).

Exclusion Criteria:

Bacterial conjunctivitis diagnosed >= 7 days ago;
bacterial infection due to trauma or foreign body;
dacryocystitis;
corneal ulceration or keratitis;
viral ocular infection; closed angle glaucoma;
acute allergy conjunctivitis;
clinically significant ocular abnormality;
organic amblyopia, monophthalmia;
corrected visual acuity below 20/100;
contact lens wearer;
newborn (i.e. 0-2 months old) not born at term (< 37 weeks of amenorrhea);
ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months;
ocular laser treatment in last 3 months;
systemic macrolide antibiotics in last month;
systemic steroids in last 2 weeks or during the study;
topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) in last week;
topical (ocular, nasal, bronchial etc.) treatments and/or systemic NSAIDs in last day;
immunosuppressives and/or any systemic antibiotic on D0.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357773

Sponsors and Collaborators

Laboratoires Thea

Investigators

Principal Investigator:

Isabelle COCHEREAU, Professor

CHU d'Angers, France

More Information

No publications provided

Study ID Numbers:	LT1225-PIII-11/03
Study First Received:	July 25, 2006
Last Updated:	July 26, 2006
ClinicalTrials.gov Identifier:	NCT00357773 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Tobramycin
Azithromycin

Eye Diseases
Eye Infections
Tetrahydrozoline
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections, Bacterial
Anti-Infective Agents
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Conjunctivitis

Infection
Conjunctival Diseases
Pharmacologic Actions
Anti-Bacterial Agents
Azithromycin
Therapeutic Uses

ClinicalTrials.gov processed this record on May 07, 2009