Azithromycin Level in Tears and in Conjunctiva in 36 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

2003-02-28

Study Completion Date

2003-03-31

Brief Summary

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To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation.

To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

Detailed Description

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The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

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

SINGLE

Interventions

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Azithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent;
* Healthy volunteers;
* Registered in the national register of healthy volunteers;
* Male or female aged from 18 to 45 years old;
* Able to understand the study instructions;
* Likely to comply with the study schedule and treatment;
* Normal subjective ocular symptoms, Schirmer test \> 10 mm in 5 min and corrected visual acuity \>= 6/10 in both eyes

Exclusion Criteria

* Ocular trauma, infection or inflammation within the last 3 months;
* Blepharitis;
* Conjunctival hyperaemia (score \>= 2);
* Fluorescein-stained punctuations (score \>= 1b);
* Hypersensitivity to one of the products used in the study;
* Clinically relevant allergy;
* Medical or surgical history incompatible with the study;
* Recent acute illness;
* Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
* Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
* Systemic antibiotics and ocular medications within the last month;
* Contact lenses within the last week;
* Any medication on Day 0 and during the study (except paracetamol and 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-PI4-11/02(F)

Identifier Type: -

Identifier Source: org_study_id