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

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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.

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.


Condition or disease Intervention/treatment Phase
Non-infectious Anterior Uveitis Drug: NS2 Drug: Prednisolone acetate ophthalmic suspension (1%) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: NS2
NS2 ophthalmic drops (0.5%) in the affected eye
Drug: NS2
NS2 ophthalmic drops (0.5%)

Experimental: NS2 and Pred Forte
NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Drug: NS2
NS2 ophthalmic drops (0.5%)

Drug: Prednisolone acetate ophthalmic suspension (1%)
Other Name: Pred Forte

Active Comparator: Pred Forte
Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Drug: Prednisolone acetate ophthalmic suspension (1%)
Other Name: Pred Forte




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406209


Locations
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United States, California
Hull Eye Center
Lancaster, California, United States, 93534
United States, Colorado
Colorado Retina Associates,PC
Golden, Colorado, United States, 80401
United States, Connecticut
Eye Center of Southern Connecticut
Hamden, Connecticut, United States, 06518-3144
United States, Florida
Bascom Palmer Eye Institute
Plantation, Florida, United States, 33324
United States, Massachusetts
Valley Eye Physicians & Surgeons
Ayer, Massachusetts, United States, 01940
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, United States, 02451
United States, Michigan
Oakland Ophthalmic Surgery
Birmingham, Michigan, United States, 48009
United States, Missouri
Lifelong Vision Foundation
Chesterfield, Missouri, United States, 63017
Tauber Eye Center
Kansas City, Missouri, United States, 64111
United States, Nebraska
UNMC Stanley Truhlsen Eye Institute
Omaha, Nebraska, United States, 68106
United States, New Jersey
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, United States, 07650
United States, Pennsylvania
Mid-Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Houston Eye Associates
Houston, Texas, United States, 77025
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
Investigators
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Principal Investigator: C.Stephen Foster, MD, FACS, FACR Massachusetts Eye Research and Surgery Institution

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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02406209     History of Changes
Other Study ID Numbers: NS2-02
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: February 2019
Keywords provided by Aldeyra Therapeutics, Inc.:
uveitis
acute uveitis
anterior uveitis
NS2
Aldeyra
prednisolone acetate
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents