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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357383
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006
  Purpose

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


Condition Intervention Phase
Eye Infections, Bacterial
Drug: Azithromycin (T1225)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Ocular pharmacokinetic in tears

Secondary Outcome Measures:
  • Tolerance

Study Start Date: October 2002
Estimated Study Completion Date: October 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357383

Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Didier CHASSARD, Dr ASTER, Paris, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357383     History of Changes
Other Study ID Numbers: LT1225-PI3-07/02(F)
Study First Received: July 25, 2006
Last Updated: July 26, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Infection
Eye Diseases
Ophthalmic Solutions
Azithromycin
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 19, 2014