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Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00357292
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 27, 2006
Information provided by:
Laboratoires Thea

July 25, 2006
July 27, 2006
July 27, 2006
March 2002
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  • Ocular subjective symptoms
  • Ocular objective symptoms
Same as current
No Changes Posted
  • Ocular pharmacokinetic.
  • Ocular and systemic adverse events.
Same as current
Not Provided
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Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 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, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation
The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Eye Infections, Bacterial
Drug: Azithromycin (T1225)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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April 2002
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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;
  • Blepharitis;
  • Conjunctival hyperaemia (score >= 2 +);
  • Watering (score >= 2);
  • Contact lenses;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment within the last month;
  • Systemic antibiotics within the last 7 days;
  • Any medication during the study (except: Paracetamol and contraceptives).
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Laboratoires Thea
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Principal Investigator: Khalid TABBARA, Professor The Eye Center, Riyadh (Saudi Arabia)
Laboratoires Thea
July 2006

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