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Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Primary Purpose

Eye Infections, Bacterial

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Infections, Bacterial

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written informed consent; Healthy volunteers; Registered in the national register of healthy volunteers; Male or female aged from 18 to 45 years old; Able to understand the study instructions; Likely to comply with the study schedule and treatment; Normal subjective ocular symptoms, Schirmer test > 10 mm in 5 min and corrected visual acuity >= 6/10 in both eyes Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; Blepharitis; Conjunctival hyperaemia (score >= 2); Fluorescein-stained punctuations (score >= 1b); Hypersensitivity to one of the products used in the study; Clinically relevant allergy; Medical or surgical history incompatible with the study; Recent acute illness; Ocular surgery, including LASIK, LASEK and PRK within the last 12 months; Other ocular lasers or Zithromax® or Azadose® within the last 3 months; Systemic antibiotics and ocular medications within the last month; Contact lenses within the last week; Any medication on Day 0 and during the study (except paracetamol and contraceptives).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
    Azithromycin Tear Concentrations on Day 7.

    Secondary Outcome Measures

    Tolerance

    Full Information

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

    Unique Protocol Identification Number
    NCT00356772
    Brief Title
    Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
    Official Title
    Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laboratoires Thea

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation. To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7
    Detailed Description
    The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin
    Primary Outcome Measure Information:
    Title
    Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
    Title
    Azithromycin Tear Concentrations on Day 7.
    Secondary Outcome Measure Information:
    Title
    Tolerance

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Written informed consent; Healthy volunteers; Registered in the national register of healthy volunteers; Male or female aged from 18 to 45 years old; Able to understand the study instructions; Likely to comply with the study schedule and treatment; Normal subjective ocular symptoms, Schirmer test > 10 mm in 5 min and corrected visual acuity >= 6/10 in both eyes Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; Blepharitis; Conjunctival hyperaemia (score >= 2); Fluorescein-stained punctuations (score >= 1b); Hypersensitivity to one of the products used in the study; Clinically relevant allergy; Medical or surgical history incompatible with the study; Recent acute illness; Ocular surgery, including LASIK, LASEK and PRK within the last 12 months; Other ocular lasers or Zithromax® or Azadose® within the last 3 months; Systemic antibiotics and ocular medications within the last month; Contact lenses within the last week; Any medication on Day 0 and during the study (except paracetamol and contraceptives).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claude DUBRAY, Professor
    Organizational Affiliation
    Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

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