Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00356772
First received: July 25, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Eye Infections, Bacterial
Drug: Azithromycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
  • Azithromycin Tear Concentrations on Day 7.

Secondary Outcome Measures:
  • Tolerance

Study Start Date: February 2003
Estimated Study Completion Date: March 2003
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356772

Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Claude DUBRAY, Professor Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356772     History of Changes
Other Study ID Numbers: LT1225-PI4-11/02(F)
Study First Received: July 25, 2006
Last Updated: July 25, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Infection
Eye Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014