Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers
Phase 1
Completed
- Conditions
- Eye Infections, Bacterial
- Registration Number
- NCT00357539
- Lead Sponsor
- Laboratoires Thea
- 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%) 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;
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Subjective ocular symptoms Objective ocular symptoms
- Secondary Outcome Measures
Name Time Method Systemic adverse events Ocular adverse events Ocular pharmacokinetic
Trial Locations
- Locations (1)
Unité de Pharmacologie Clinique
🇫🇷Clermont Ferrand, France