Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
Information source: Laboratoires Thea
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eye Infections, Bacterial
Intervention: Azithromycin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Laboratoires Thea Official(s) and/or principal investigator(s):
Claude DUBRAY, Professor, Principal Investigator, Affiliation: Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
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
Clinical Details
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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.Azithromycin Tear Concentrations on Day 7.
Secondary outcome: Tolerance
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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).
Locations and Contacts
Additional Information
Starting date: February 2003
Ending date: March 2003
Last updated: July 25, 2006
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