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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NS2 | Experimental | NS2 ophthalmic drops (0.5%) in the affected eye |
|
| NS2 and Pred Forte | Experimental | NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye |
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| Pred Forte | Active Comparator | Prednisolone acetate ophthalmic suspension (1%) in the affected eye |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NS2 | Drug | NS2 ophthalmic drops (0.5%) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell Grade at Week 8 | Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. | The efficacy assessment period was assessed at Week 8; baseline was Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C.Stephen Foster, MD, FACS, FACR | Massachusetts Eye Research and Surgery Institution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Eye Center | Lancaster | California | 93534 | United States | ||
| Colorado Retina Associates,PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32955967 | Derived | Mandell KJ, Clark D, Chu DS, Foster CS, Sheppard J, Brady TC. Randomized Phase 2 Trial of Reproxalap, a Novel Reactive Aldehyde Species Inhibitor, in Patients with Noninfectious Anterior Uveitis: Model for Corticosteroid Replacement. J Ocul Pharmacol Ther. 2020 Dec;36(10):732-739. doi: 10.1089/jop.2020.0056. Epub 2020 Sep 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NS2 Ophthalmic Drops (0.5%) | NS2 administered four times daily (QID) for approximately 6 weeks |
| FG001 | NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops | NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Prednisolone acetate ophthalmic suspension (1%) |
| Drug |
|
|
| Golden |
| Colorado |
| 80401 |
| United States |
| Eye Center of Southern Connecticut | Hamden | Connecticut | 06518-3144 | United States |
| Bascom Palmer Eye Institute | Plantation | Florida | 33324 | United States |
| Valley Eye Physicians & Surgeons | Ayer | Massachusetts | 01940 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Massachusetts Eye Research and Surgery Institution (MERSI) | Waltham | Massachusetts | 02451 | United States |
| Oakland Ophthalmic Surgery | Birmingham | Michigan | 48009 | United States |
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| UNMC Stanley Truhlsen Eye Institute | Omaha | Nebraska | 68106 | United States |
| Metropolitan Eye Research & Surgery Institute | Palisades Park | New Jersey | 07650 | United States |
| Mid-Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| FG002 | Pred Forte® (1%) Ophthalmic Drops | Pred Forte® QID tapered through Week 6 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NS2 Ophthalmic Drops (0.5%) | NS2 administered four times daily (QID) for approximately 6 weeks |
| BG001 | NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops | NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4 |
| BG002 | Pred Forte® (1%) Ophthalmic Drops | Pred Forte® QID tapered through Week 6 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anterior Chamber Cell Grade at Week 8 | Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. | Modified intent-to-treat | Posted | Least Squares Mean | Standard Error | units on a scale | The efficacy assessment period was assessed at Week 8; baseline was Day 1. |
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The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NS2 Ophthalmic Drops (0.5%) | NS2 administered four times daily (QID) for approximately 6 weeks | 0 | 15 | 0 | 15 | 8 | 15 |
| EG001 | NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops | NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4 | 0 | 16 | 0 | 16 | 8 | 16 |
| EG002 | Pred Forte® (1%) Ophthalmic Drops | Pred Forte® QID tapered through Week 6 | 0 | 14 | 0 | 14 | 3 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iridocyclitis | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cystoid macular oedema | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Photophobia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Visual acuity reduced | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Ligament rupture | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Ligament sprain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Syncope | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D014606 | Uveitis, Anterior |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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