Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Phase 1

Completed

• Conditions: Eye Infections, Bacterial

• Registration Number: NCT00357383
• Lead Sponsor: Laboratoires Thea

Brief Summary

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Detailed Description

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

Study Timeline

• Study Start: 2002-10
• Study Completion: 2002-10
• Status Verified: 2006-07
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-26
• Last Update Submitted: 2006-07-26
• Study First Posted: 2006-07-27
• Last Update Posted: 2006-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female aged from 18 to 45 years old;
• Written informed consent;
• Healthy volunteers without any subjective ocular symptom;
• Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);
• Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion Criteria

• Ocular trauma, infection or inflammation within the last 3 months;
• number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
• number of corneal stained punctuations >= 5;
• blepharitis, conjunctivitis, uveitis;
• contact lenses;
• topical ocular treatment within the last month;
• ocular laser within the last 3 months;
• ocular surgery, including LASIK and PRK, within the last 12 months;
• systemic macrolide within the last month;
• medication during the study (except: paracetamol and contraceptives).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ocular pharmacokinetic in tears

Secondary Outcome Measures

Name	Time	Method
Tolerance