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Sponsored by: |
Laboratoires Thea |
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Information provided by: | Laboratoires Thea |
ClinicalTrials.gov Identifier: | NCT00356772 |
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 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | March 2003 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Bacterial Infections Lacerations Anti-Infective Agents Anti-Bacterial Agents Eye Infections, Bacterial |
Azithromycin Eye Diseases Eye Infections Tetrahydrozoline Healthy |
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Eye Infections, Bacterial Therapeutic Uses |
Azithromycin Eye Diseases Eye Infections Infection Pharmacologic Actions |