Status:

COMPLETED

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

Lead Sponsor:

Laboratoires Thea

Conditions:

Eye Infections, Bacterial

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

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.

Detailed 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 co...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2002

Trial Type :

INTERVENTIONAL

End Date :

June 1 2002

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00356850

Start Date

May 1 2002

End Date

June 1 2002

Last Update

July 26 2006

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