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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002334-21 | EudraCT Number |
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A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
Each subject will receive the following treatments:
There will be a minimum washout of 7 days between each treatment period (last dose of previous period to first dose of subsequent period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMA0076 Formulation A | Experimental | Topical Ocular Drop BID X 1 wk |
|
| AMA0076 Formulation B | Experimental | Topical Ocular Drop BID X 1wk |
|
| AMA0076 Formulation C | Experimental | Topical Ocular Drop BID X 1 wk |
|
| Placebo | Placebo Comparator | Topical Ocular Drop BID X 1 wk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMA0076 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | The primary endpoint is the comparison of Intraocular Pressure assessments taken at pre-treatment on Day -1 and on Day 7 for each diurnal time point (0, 2, 4 and 8 h post-anticipated dose [Day -1] or post-dose [Day 7]) for each treatment period between active treatment and placebo. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The secondary endpoints are:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair, MD | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruddington | Nottingham | NG11 6GS | United Kingdom |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Drug |
|
| 7 days |