Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

Laboratoires Thea

Overview

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

The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Eye Infections, Bacterial

Interventions

Azithromycin (T1225)DRUG

Eligibility

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

Medical Language ↔ Plain English

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; * Blepharitis; * Conjunctival hyperaemia (score \>= 2 +); * Watering (score \>= 2); * Contact lenses; * Ocular surgery, including LASIK and PRK, within the last 12 months; * Topical ocular treatment within the last month; * Systemic antibiotics within the last 7 days; * Any medication during the study (except: Paracetamol and contraceptives).

Outcomes

Primary Outcomes

Ocular subjective symptoms

Ocular objective symptoms

Secondary Outcomes

Ocular pharmacokinetic.

Ocular and systemic adverse events.

Data from ClinicalTrials.gov

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