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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00356850
First received: July 25, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Eye Infections, Bacterial
 Drug: Azithromycin
 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: Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Eye Infections
U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Area Under the Curve from 0 to 24 hours (AUC0-24h)
  • Elimination half-life (t1/2)
  • Maximum Concentration (Cmax)
  • Concentration 24 hours after instillation (C24h)

Secondary Outcome Measures:
  • Tolerance

Study Start Date: May 2002
Estimated Study Completion Date: June 2002
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 concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356850

Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Claude DUBRAY, Professor Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356850     History of Changes
Other Study ID Numbers: LT1225-PI2-03/02(F)
Study First Received: July 25, 2006
Last Updated: July 25, 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
 Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013