Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Thea Pharma

Status and phase

Completed

Phase 1

Conditions

Eye Infections, Bacterial

Treatments

Drug: Azithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00356772

LT1225-PI4-11/02(F)

Details and patient eligibility

About

To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation.

To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

Full description

The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written informed consent;
Healthy volunteers;
Registered in the national register of healthy volunteers;
Male or female aged from 18 to 45 years old;
Able to understand the study instructions;
Likely to comply with the study schedule and treatment;
Normal subjective ocular symptoms, Schirmer test > 10 mm in 5 min and corrected visual acuity >= 6/10 in both eyes

Exclusion criteria

Ocular trauma, infection or inflammation within the last 3 months;
Blepharitis;
Conjunctival hyperaemia (score >= 2);
Fluorescein-stained punctuations (score >= 1b);
Hypersensitivity to one of the products used in the study;
Clinically relevant allergy;
Medical or surgical history incompatible with the study;
Recent acute illness;
Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
Systemic antibiotics and ocular medications within the last month;
Contact lenses within the last week;
Any medication on Day 0 and during the study (except paracetamol and contraceptives).