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Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357539
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006
History of Changes

July 25, 2006
July 26, 2006
February 2002
Not Provided
  • Subjective ocular symptoms
  • Objective ocular symptoms
Same as current
Complete list of historical versions of study NCT00357539 on ClinicalTrials.gov Archive Site
  • Systemic adverse events
  • Ocular adverse events
  • Ocular pharmacokinetic
Same as current
Not Provided
Not Provided
 
Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers
Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety 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
March 2002
Not Provided

Inclusion Criteria:

  • Male or female aged from 18 to 45 years old;
  • Written informed consent;
  • Healthy volunteers (without any ocular symptom);
  • Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) >= 10 seconds - lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - lissamine green test total score < 4).

Exclusion Criteria:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Conjunctival hyperaemia score >= 2, watering score >= 2, folliculo-papillary conjunctivitis score >= 2, number of fluorescein-stained punctuations >= 10;
  • Blepharitis, conjunctivitis, uveitis;
  • Ocular laser treatment within the last 3 months;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment during the last month;
  • Ocular antibiotics within the last 7 days;
  • 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
France
 
NCT00357539
LT1225-PI1-09/01(F)
Not Provided
Not Provided
Laboratoires Thea
Not Provided
Principal Investigator: Claude DUBRAY, Professor Unité de Pharmacologie Clinique - Clermont-Ferrand (France)
Laboratoires Thea
July 2006

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