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To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.
The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin (T1225) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective ocular symptoms | ||
| Objective ocular symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic adverse events | ||
| Ocular adverse events | ||
| Ocular pharmacokinetic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude DUBRAY, Professor | Unité de Pharmacologie Clinique - Clermont-Ferrand (France) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Pharmacologie Clinique | Clermont-Ferrand | 63009 | France |
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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 |