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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014