Status:
COMPLETED
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
Lead Sponsor:
Laboratoires Thea
Conditions:
Eye Infections, Bacterial
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2). To assess azi...
Detailed Description
The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations i...
Eligibility Criteria
Inclusion
- Male or female aged from 18 to 45 years old;
- Written informed consent;
- Healthy volunteers without any subjective ocular symptom;
- Normal ocular examination in both eyes (corrected visual acuity \>= 6/10, normal slit lamp examination, tear prism height \> 0.1mm, tear break-up time (BUT) \>= 10 seconds, lissamine green test score \< 4);
- Registered, or agreed to be registered, in the national register of healthy volunteers
Exclusion
- Ocular trauma, infection or inflammation within the last 3 months;
- number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
- number of corneal stained punctuations \>= 5;
- blepharitis, conjunctivitis, uveitis;
- contact lenses;
- topical ocular treatment within the last month;
- ocular laser within the last 3 months;
- ocular surgery, including LASIK and PRK, within the last 12 months;
- systemic macrolide within the last month;
- medication during the study (except: paracetamol and contraceptives).
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357383
Start Date
October 1 2002
End Date
October 1 2002
Last Update
July 27 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.