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

Thea Pharma

Status and phase

Completed

Phase 1

Conditions

Eye Infections, Bacterial

Treatments

Drug: Azithromycin (T1225)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00357539

LT1225-PI1-09/01(F)

Details and patient eligibility

About

To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

Full 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.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).