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

Thea Pharma

Status and phase: Completed; Phase 1

Conditions: Eye Infections, Bacterial

Treatments: Drug: Azithromycin (T1225)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357292

LT1225-PI1-09/01(AS)

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind