A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Status: | Completed |
---|---|
Conditions: | Ocular, Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 3/14/2019 |
Start Date: | March 2015 |
End Date: | April 2016 |
A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis
This is a randomized, multi-center, investigator masked, comparator controlled study. The
purpose of this study is to determine the efficacy and safety of NS2 in patients with
non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple
doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.
Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a
small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.
purpose of this study is to determine the efficacy and safety of NS2 in patients with
non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple
doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.
Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a
small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.
Inclusion Criteria:
- Non-infectious anterior uveitis
- Grade 1 - Grade 3 anterior chamber cell count
- Subjects must have Intraocular pressure <25 mmHg at baseline and may only administer a
maximum of 1 topical medication to control Intraocular pressure in the study eye.
- Visual acuity ≥ 20/200 in the study eye
Exclusion Criteria:
- Severe/serious ocular pathology
- Active intermediate or posterior uveitis.
- Previous anterior uveitis episode in the study eye within 4 weeks of Visit 1
- Oral corticosteroids within 14 days of Visit 1
- Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6
months.
We found this trial at
15
sites
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