Clinical Trial: A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis
Brief Summary:
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.
Detailed Summary:
Sponsor: Aldeyra Therapeutics, Inc.
Current Primary Outcome:
- Grade of anterior chamber cell count measured by slit lamp examination. The primary outcome is not specifically defined however anterior uveitis clinical outcomes will be measured. [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]Change from baseline in Grade of anterior chamber cell count
- Grade of anterior chamber flare measured by slit lamp examination [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]Change from baseline in Grade of Anterior chamber cell count
- Grade of limbal injection measured by slit lamp examination [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]Change from baseline in limbal injection
- Grade of hypopion measured by slit lamp examination [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]Change from baseline in hypopion
- Grade of peripheral anterior synechiae measured by slit lamp examination [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]Change from baseline in peripheral anterior synechiae
- Grade of keratic precipitates measured by slit lamp examination [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]Change from baseline in keratic precipitates
- Grade of posterior synechiae measured by slit lamp examination [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of subjects with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8, Week 9 ]
Change from baseline in the number of treatment emergent adverse events.
Original Secondary Outcome: Same as current
Information By: Aldeyra Therapeutics, Inc.
Dates:
Date Received: March 26, 2015
Date Started: March 2015
Date Completion:
Last Updated: May 25, 2016
Last Verified: May 2016