Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Laboratoires Thea1 site in 1 countryFebruary 2002

ConditionsEye Infections, Bacterial

DrugsAzithromycin (T1225)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Eye Infections, Bacterial
Sponsor: Laboratoires Thea
Locations: 1
Primary Endpoint: Objective ocular symptoms
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

March 2002

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratoires Thea

Eligibility Criteria

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).