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Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00356772
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : July 26, 2006
Information provided by:
Laboratoires Thea

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

Condition or disease Intervention/treatment Phase
Eye Infections, Bacterial Drug: Azithromycin Phase 1

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : February 2003
Estimated Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Tolerance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356772

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

ClinicalTrials.gov Identifier: NCT00356772     History of Changes
Other Study ID Numbers: LT1225-PI4-11/02(F)
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: July 26, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Eye Diseases