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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bacterial Infections
Conjunctival Diseases
Eye Diseases
Eye Infections
Eye Infections, Bacterial
Infection

ClinicalTrials.gov processed this record on November 24, 2014