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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2002-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eye Infections, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Azithromycin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Claude DUBRAY, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre de Pharmacologie Clinique - Clermont-Ferrand (France)

Other Identifiers

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LT1225-PI2-03/02(F)

Identifier Type: -

Identifier Source: org_study_id