Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357539
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Subjective ocular symptoms
  • Objective ocular symptoms

Secondary Outcome Measures:
  • Systemic adverse events
  • Ocular adverse events
  • Ocular pharmacokinetic

Study Start Date: February 2002
Estimated Study Completion Date: March 2002
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.

  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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357539

Locations
France
Unité de Pharmacologie Clinique
Clermont Ferrand, France, 63009
Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Claude DUBRAY, Professor Unité de Pharmacologie Clinique - Clermont-Ferrand (France)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357539     History of Changes
Other Study ID Numbers: LT1225-PI1-09/01(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
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014