Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02406209
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE April 2, 2015
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • 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 ]
    Change from baseline in posterior synechiae
  • Ocular pain score on the visual analog scale [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]
    Change from baseline in ocular pain score
  • Visual acuity measured by a standardized eye chart (ETDRS or Snellen) [ Time Frame: Day 1, Day 4, Week 1, Week 2, Week 4, Week 8 ]
    Change from baseline in visual acuity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02406209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-infectious Anterior Uveitis
Intervention  ICMJE
  • Drug: NS2
    NS2 ophthalmic drops (0.5%)
  • Drug: Prednisolone acetate ophthalmic suspension (1%)
    Other Name: Pred Forte
Study Arms  ICMJE
  • Experimental: NS2
    NS2 ophthalmic drops (0.5%) in the affected eye
    Intervention: Drug: NS2
  • Experimental: NS2 and Pred Forte
    NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
    Interventions:
    • Drug: NS2
    • Drug: Prednisolone acetate ophthalmic suspension (1%)
  • Active Comparator: Pred Forte
    Prednisolone acetate ophthalmic suspension (1%) in the affected eye
    Intervention: Drug: Prednisolone acetate ophthalmic suspension (1%)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02406209
Other Study ID Numbers  ICMJE NS2-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aldeyra Therapeutics, Inc.
Study Sponsor  ICMJE Aldeyra Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: C.Stephen Foster, MD, FACS, FACR Massachusetts Eye Research and Surgery Institution
PRS Account Aldeyra Therapeutics, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP