Status:
COMPLETED
Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 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, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation
Detailed Description
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.
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;
- 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).
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357292
Start Date
March 1 2002
End Date
April 1 2002
Last Update
July 27 2006
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