Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers
Phase 1
Completed
- Conditions
- Eye Infections, Bacterial
- Registration Number
- NCT00357292
- Lead Sponsor
- Laboratoires Thea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ocular subjective symptoms Ocular objective symptoms
- Secondary Outcome Measures
Name Time Method Ocular pharmacokinetic. Ocular and systemic adverse events.