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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 azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period
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 in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin (T1225) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular pharmacokinetic in tears |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier CHASSARD, Dr | ASTER, Paris, France | Principal Investigator |
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| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| D005128 |
| Eye Diseases |
| Organic Chemicals |