Status:
COMPLETED
Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers
Lead Sponsor:
Laboratoires Thea
Conditions:
Eye Infections, Bacterial
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.
Detailed Description
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%...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357539
Start Date
February 1 2002
End Date
March 1 2002
Last Update
July 27 2006
Active Locations (1)
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1
Unité de Pharmacologie Clinique
Clermont-Ferrand, France, 63009