A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
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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
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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 |
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
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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
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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
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Drug: Prednisolone acetate ophthalmic suspension (1%)
Other Name: Pred Forte |
- 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
- 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 |
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.

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
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 |
Principal Investigator: | C.Stephen Foster, MD, FACS, FACR | Massachusetts Eye Research and Surgery Institution |
Responsible Party: | Aldeyra Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02406209 |
Other Study ID Numbers: |
NS2-02 |
First Posted: | April 2, 2015 Key Record Dates |
Last Update Posted: | March 12, 2019 |
Last Verified: | February 2019 |
uveitis acute uveitis anterior uveitis |
NS2 Aldeyra prednisolone acetate |
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 |