Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

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

July 25, 2006
July 26, 2006
February 2002
Not Provided
  • Subjective ocular symptoms
  • Objective ocular symptoms
Same as current
No Changes Posted
  • 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.
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 Identifier (NCT Number) in Medline.
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).
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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