Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in 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

NCT00357383

LT1225-PI3-07/02(F)

Details and patient eligibility

About

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Full description

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

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 subjective ocular symptom;
Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);
Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion criteria

Ocular trauma, infection or inflammation within the last 3 months;
number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
number of corneal stained punctuations >= 5;
blepharitis, conjunctivitis, uveitis;
contact lenses;
topical ocular treatment within the last month;
ocular laser within the last 3 months;
ocular surgery, including LASIK and PRK, within the last 12 months;
systemic macrolide within the last month;
medication during the study (except: paracetamol and contraceptives).