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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357773
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

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

ClinicalTrials.gov Identifier: NCT00357773     History of Changes
Other Study ID Numbers: LT1225-PIII-11/03
Study First Received: July 25, 2006
Last Updated: July 26, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
 Infection
Tobramycin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013