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Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357383
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006

July 25, 2006
July 26, 2006
October 2002
Not Provided
Ocular pharmacokinetic in tears
Same as current
Complete list of historical versions of study NCT00357383 on ClinicalTrials.gov Archive Site
Tolerance
Same as current
Not Provided
Not Provided
 
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Eye Infections, Bacterial
Drug: Azithromycin (T1225)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2002
Not Provided

Inclusion Criteria:

  • Male or female aged from 18 to 45 years old;
  • Written informed consent;
  • Healthy volunteers without any subjective ocular symptom;
  • Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);
  • Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion Criteria:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
  • number of corneal stained punctuations >= 5;
  • blepharitis, conjunctivitis, uveitis;
  • contact lenses;
  • topical ocular treatment within the last month;
  • ocular laser within the last 3 months;
  • ocular surgery, including LASIK and PRK, within the last 12 months;
  • systemic macrolide within the last month;
  • medication during the study (except: paracetamol and contraceptives).
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00357383
LT1225-PI3-07/02(F)
Not Provided
Not Provided
Laboratoires Thea
Not Provided
Principal Investigator: Didier CHASSARD, Dr ASTER, Paris, France
Laboratoires Thea
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP