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Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT00356772
Collaborator
(none)
28
Duration (Days)

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Feb 1, 2003
Study Completion Date :
Mar 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Laboratoires Thea

Investigators

  • Principal Investigator: Claude DUBRAY, Professor, Centre de Pharmacologie Clinique - Clermont-Ferrand (France)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00356772
Other Study ID Numbers:
  • LT1225-PI4-11/02(F)
First Posted:
Jul 26, 2006
Last Update Posted:
Jul 26, 2006
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Azithromycin

Study Results

No Results Posted as of Jul 26, 2006