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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356850
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : July 26, 2006
Information provided by:
Laboratoires Thea

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.

Condition or disease Intervention/treatment Phase
Eye Infections, Bacterial Drug: Azithromycin Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2002
Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Tolerance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00356850

Sponsors and Collaborators
Laboratoires Thea
Principal Investigator: Claude DUBRAY, Professor Centre de Pharmacologie Clinique - Clermont-Ferrand (France) Identifier: NCT00356850     History of Changes
Other Study ID Numbers: LT1225-PI2-03/02(F)
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: July 26, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Eye Diseases