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

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT00357539
Collaborator
(none)
1
Location
28
Duration (Days)

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Feb 1, 2002
Study Completion Date :
Mar 1, 2002

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00357539
Other Study ID Numbers:
  • LT1225-PI1-09/01(F)
First Posted:
Jul 27, 2006
Last Update Posted:
Jul 27, 2006
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Azithromycin

Study Results

No Results Posted as of Jul 27, 2006