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The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.
This first in-human, phase 2 proof of concept study aims to show that the formulation at two concentrations is safe and well tolerated over a period of 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus ophthalmic solution (high dose) | Active Comparator |
| |
| Tacrolimus ophthalmic solution (low dose) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus ophthalmic solution | Drug | high and low dose treatment will be compared over 6 weeks treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | ocular and non-ocular adverse events | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Meides, PhD | Contact | +49 622150259 | 0 | ameides@novaliq.com |
| Name | Affiliation | Role |
|---|---|---|
| Sonja Kroesser, PhD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Recruiting | Miami | Florida | 33136 | United States |
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| Massachusetts Eye Research and Surgery Institution | Recruiting | Waltham | Massachusetts | 02451 | United States |
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| Metropolitan Eye Research and Surgery Institute | Recruiting | Palisades Park | New Jersey | 07650 | United States |
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| Valley Retina Institute, P.A. | Recruiting | McAllen | Texas | 78503 | United States |
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| Virginia Eye Consultants | Recruiting | Norfolk | Virginia | 23502 | United States |
|