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

Primary Purpose

Conjunctivitis, Bacterial

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Azithromycin (T1225)
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis, Bacterial

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    July 25, 2006
    Last Updated
    July 26, 2006
    Sponsor
    Laboratoires Thea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00357773
    Brief Title
    Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laboratoires Thea

    4. Oversight

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Conjunctivitis, Bacterial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin (T1225)
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Clinical cure at Day 3
    Title
    Microbiological cure at Day 3 and Day 9
    Title
    Global efficacy.
    Title
    Tolerance

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Isabelle COCHEREAU, Professor
    Organizational Affiliation
    CHU d'Angers, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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