Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers - Full Text View

Sponsored by:	Laboratoires Thea
Information provided by:	Laboratoires Thea
ClinicalTrials.gov Identifier:	NCT00356772

Purpose

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

Condition	Intervention	Phase
Eye Infections, Bacterial	Drug: Azithromycin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Eye Infections

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:

Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
Azithromycin Tear Concentrations on Day 7.

Secondary Outcome Measures:

Tolerance

Study Start Date:	February 2003
Estimated Study Completion Date:	March 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356772

Sponsors and Collaborators

Laboratoires Thea

Investigators

Principal Investigator:

Claude DUBRAY, Professor

Centre de Pharmacologie Clinique - Clermont-Ferrand (France)

More Information

No publications provided

Study ID Numbers:	LT1225-PI4-11/02(F)
Study First Received:	July 25, 2006
Last Updated:	July 25, 2006
ClinicalTrials.gov Identifier:	NCT00356772 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Bacterial Infections
Lacerations
Anti-Infective Agents
Anti-Bacterial Agents
Eye Infections, Bacterial

Azithromycin
Eye Diseases
Eye Infections
Tetrahydrozoline
Healthy

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Eye Infections, Bacterial
Therapeutic Uses

Azithromycin
Eye Diseases
Eye Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009