Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Eye Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356772
• Other study ID #: LT1225-PI4-11/02(F)
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: July 25, 2006
• Start date: February 2003
• Est. completion date: March 2003

Study information

• Verified date: July 2006
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Eye Infections
• Eye Infections, Bacterial

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
Primary	Azithromycin Tear Concentrations on Day 7.
Secondary	Tolerance