Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

July 25, 2006 updated by: Laboratoires Thea

Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers

To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single 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/female aged from 18 to 45 years;
  • Written informed consent;
  • Healthy volunteers without any subjective ocular symptom;
  • Corrected visual acuity >= 6/10;
  • Registered in the national register of healthy volunteers

Exclusion Criteria:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Conjunctival hyperaemia (score >= 2);
  • Folliculo-papillary conjunctivitis (score >= 2);
  • Topical ocular treatment within the last month;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Other ocular laser within the last 3 months;
  • Zithromax® and Azadose® within the last 3 months;
  • Medication during the study (except: paracetamol, 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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area Under the Curve from 0 to 24 hours (AUC0-24h)
Elimination half-life (t1/2)
Maximum Concentration (Cmax)
Concentration 24 hours after instillation (C24h)

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

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

May 1, 2002

Study Completion

June 1, 2002

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

July 26, 2006

Last Update Submitted That Met QC Criteria

July 25, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT1225-PI2-03/02(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.

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