Non-infectious Anterior UveitisPhase 2NCT02406209
A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
A Phase 2 study testing NS2 and Prednisolone acetate ophthalmic suspension (1%) in people with Non-infectious Anterior Uveitis, run by Aldeyra Therapeutics, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-infectious Anterior Uveitis
- What is being tested?
- NS2 and Prednisolone acetate ophthalmic suspension (1%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Valley Eye Physicians & Surgeons
Ayer, Massachusetts, 01940
Oakland Ophthalmic Surgery
Birmingham, Michigan, 48009
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Colorado Retina Associates,PC
Golden, Colorado, 80401
Eye Center of Southern Connecticut
Hamden, Connecticut, 06518-3144
Houston Eye Associates
Houston, Texas, 77025
Tauber Eye Center
Kansas City, Missouri, 64111
Hull Eye Center
Lancaster, California, 93534
Virginia Eye Consultants
Norfolk, Virginia, 23502
UNMC Stanley Truhlsen Eye Institute
Omaha, Nebraska, 68106
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, 07650
Mid-Atlantic Retina
Philadelphia, Pennsylvania, 19107
Bascom Palmer Eye Institute
Plantation, Florida, 33324
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, 02451
About this study
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
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.
- Conditions
- Non-infectious Anterior Uveitis
- Being tested
- NS2, Prednisolone acetate ophthalmic suspension (1%)
- Keywords
- uveitis, acute uveitis, anterior uveitis, NS2, Aldeyra, prednisolone acetate
- Medical subject headings
- Uveitis, Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS2Drug
NS2 ophthalmic drops (0.5%)
Prednisolone acetate ophthalmic suspension (1%)Drug
Also called Pred Forte
| Study group | Role | What they receive |
|---|---|---|
| NS2 | Experimental | NS2 ophthalmic drops (0.5%) in the affected eye Receives: Drug: NS2 |
| NS2 and Pred Forte | Experimental | NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye Receives: Drug: NS2; Drug: Prednisolone acetate ophthalmic suspension (1%) |
| Pred Forte | Active comparator | Prednisolone acetate ophthalmic suspension (1%) in the affected eye Receives: Drug: Prednisolone acetate ophthalmic suspension (1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The efficacy assessment period was assessed at Week 8; baseline was Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-infectious Anterior UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C.Stephen Foster, MD, FACS, FACR, Principal investigator, Massachusetts Eye Research and Surgery Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406209
- Sponsor's protocol ID
- NS2-02
- Status last verified
- Feb 2019
- First submitted
- 26 Mar 2015
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32955967
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02406209
- Acronym / sponsor ID
- NS2-02
- Conditions
- Non-infectious Anterior Uveitis
- Keywords
- uveitis, acute uveitis, anterior uveitis, NS2, Aldeyra, prednisolone acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Posted 27 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NS2 | Experimental | Drug: NS2NS2 ophthalmic drops (0.5%) in the affected eye |
| NS2 and Pred Forte | Experimental | Drug: NS2, Drug: Prednisolone acetate ophthalmic suspension (1%)NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye |
| Pred Forte | Active comparator | Drug: Prednisolone acetate ophthalmic suspension (1%)Prednisolone acetate ophthalmic suspension (1%) in the affected eye |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS2NS2 ophthalmic drops (0.5%) | Drug | NS2, NS2 and Pred Forte |
| Prednisolone acetate ophthalmic suspension (1%)Also: Pred Forte | Drug | NS2 and Pred Forte, Pred Forte |
Primary outcome
Anterior Chamber Cell Grade at Week 8
Time frame: The efficacy assessment period was assessed at Week 8; baseline was Day 1.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32955967Mandell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.Stephen Foster, MD, FACS, FACR principal investigator
Massachusetts Eye Research and Surgery Institution
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS2 and Prednisolone acetate ophthalmic suspension (1%) in people with Non-infectious Anterior Uveitis, run by Aldeyra Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Chamber Cell Grade at Week 8 (time frame: The efficacy assessment period was assessed at Week 8; baseline was Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.