Status:
COMPLETED
Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
Lead Sponsor:
Laboratoires Thea
Conditions:
Eye Infections, Bacterial
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00356772
Start Date
February 1 2003
End Date
March 1 2003
Last Update
July 26 2006
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