Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

July 25, 2006 updated by: Laboratoires Thea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Tolerance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (ESTIMATE)

July 26, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2006

Last Update Submitted That Met QC Criteria

July 25, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT1225-PI4-11/02(F)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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