Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

Laboratoires Thea

Overview

To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Eye Infections, Bacterial

Interventions

AzithromycinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male/female aged from 18 to 45 years; * Written informed consent; * Healthy volunteers without any subjective ocular symptom; * Corrected visual acuity \>= 6/10; * Registered in the national register of healthy volunteers Exclusion Criteria: * Ocular trauma, infection or inflammation within the last 3 months; * Conjunctival hyperaemia (score \>= 2); * Folliculo-papillary conjunctivitis (score \>= 2); * Topical ocular treatment within the last month; * Ocular surgery, including LASIK and PRK, within the last 12 months; * Other ocular laser within the last 3 months; * Zithromax® and Azadose® within the last 3 months; * Medication during the study (except: paracetamol, contraceptives

Outcomes

Primary Outcomes

Area Under the Curve from 0 to 24 hours (AUC0-24h)

Elimination half-life (t1/2)

Maximum Concentration (Cmax)

Concentration 24 hours after instillation (C24h)

Secondary Outcomes

Tolerance

Data from ClinicalTrials.gov

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