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