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

July 26, 2006 updated by: Laboratoires Thea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ocular pharmacokinetic in tears

Secondary Outcome Measures

Outcome Measure
Tolerance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion

October 1, 2002

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (ESTIMATE)

July 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2006

Last Update Submitted That Met QC Criteria

July 26, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT1225-PI3-07/02(F)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eye Infections, Bacterial

Clinical Trials on Azithromycin (T1225)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe