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Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT00357383
Collaborator
(none)

Study Details

Study Description

Brief Summary

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Condition or Disease Intervention/Treatment Phase
  • Drug: Azithromycin (T1225)
 Phase 1

Detailed Description

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
Study Start Date :
Oct 1, 2002
Study Completion Date :
Oct 1, 2002

Outcome Measures

Primary Outcome Measures

  1. Ocular pharmacokinetic in tears []

Secondary Outcome Measures

  1. Tolerance []

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 subjective ocular symptom;

  • Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);

  • Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion Criteria:

  • Ocular trauma, infection or inflammation within the last 3 months;

  • number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;

  • number of corneal stained punctuations >= 5;

  • blepharitis, conjunctivitis, uveitis;

  • contact lenses;

  • topical ocular treatment within the last month;

  • ocular laser within the last 3 months;

  • ocular surgery, including LASIK and PRK, within the last 12 months;

  • systemic macrolide within the last month;

  • medication during the study (except: paracetamol and contraceptives).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Laboratoires Thea

Investigators

  • Principal Investigator: Didier CHASSARD, Dr, ASTER, Paris, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00357383
Other Study ID Numbers:
  • LT1225-PI3-07/02(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