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

Thea Pharma

Status and phase: Completed; Phase 1

Conditions: Eye Infections, Bacterial

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356850

LT1225-PI2-03/02(F)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind