Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 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: NCT00357539
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 27, 2006
Information provided by:
Laboratoires Thea

Brief Summary:
To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

Condition or disease Intervention/treatment Phase
Eye Infections, Bacterial Drug: Azithromycin (T1225) Phase 1

Detailed Description:
The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
Study Start Date : February 2002
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Infections

Primary Outcome Measures :
  1. Subjective ocular symptoms
  2. Objective ocular symptoms

Secondary Outcome Measures :
  1. Systemic adverse events
  2. Ocular adverse events
  3. Ocular pharmacokinetic

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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 or female aged from 18 to 45 years old;
  • Written informed consent;
  • Healthy volunteers (without any ocular symptom);
  • Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) >= 10 seconds - lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - lissamine green test total score < 4).

Exclusion Criteria:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Conjunctival hyperaemia score >= 2, watering score >= 2, folliculo-papillary conjunctivitis score >= 2, number of fluorescein-stained punctuations >= 10;
  • Blepharitis, conjunctivitis, uveitis;
  • Ocular laser treatment within the last 3 months;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment during the last month;
  • Ocular antibiotics within the last 7 days;
  • Medication during the study (except paracetamol and 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): NCT00357539

Unité de Pharmacologie Clinique
Clermont Ferrand, France, 63009
Sponsors and Collaborators
Laboratoires Thea
Principal Investigator: Claude DUBRAY, Professor Unité de Pharmacologie Clinique - Clermont-Ferrand (France) Identifier: NCT00357539     History of Changes
Other Study ID Numbers: LT1225-PI1-09/01(F)
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: July 2006

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