Non-infectious Anterior Uveitis
Conditions
Keywords
uveitis, acute uveitis, anterior uveitis, NS2, Aldeyra, prednisolone acetate
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.
Interventions
DRUGNS2
NS2 ophthalmic drops (0.5%)
DRUGPrednisolone acetate ophthalmic suspension (1%)
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Cell Grade at Week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NS2 Ophthalmic Drops (0.5%) NS2 administered four times daily (QID) for approximately 6 weeks | 15 |
| 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 | 16 |
| Pred Forte® (1%) Ophthalmic Drops Pred Forte® QID tapered through Week 6 | 14 |
| Total | 45 |
Baseline characteristics
| Characteristic | Pred Forte® (1%) Ophthalmic Drops | Total | NS2 Ophthalmic Drops (0.5%) | NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops |
|---|---|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 11.38 | 45.4 years STANDARD_DEVIATION 15.44 | 46.8 years STANDARD_DEVIATION 13.84 | 48.0 years STANDARD_DEVIATION 19.49 |
| Height | 168.6 centimeters STANDARD_DEVIATION 10.24 | 167.7 centimeters STANDARD_DEVIATION 11.39 | 168.9 centimeters STANDARD_DEVIATION 14.45 | 165.7 centimeters STANDARD_DEVIATION 9.38 |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 14 Participants | 42 Participants | 12 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 11 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 32 Participants | 8 Participants | 12 Participants |
| Region of Enrollment United States | 14 Participants | 45 Participants | 15 Participants | 16 Participants |
| Sex: Female, Male Female | 8 Participants | 32 Participants | 10 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 5 Participants | 2 Participants |
| Weight | 78.3 kilograms STANDARD_DEVIATION 22.46 | 78.8 kilograms STANDARD_DEVIATION 21.74 | 79.7 kilograms STANDARD_DEVIATION 18.53 | 78.5 kilograms STANDARD_DEVIATION 25.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 8 / 15 | 8 / 16 | 3 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 | 0 / 14 |
Outcome results
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.
Time frame: The efficacy assessment period was assessed at Week 8; baseline was Day 1.
Population: Modified intent-to-treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Anterior Chamber Cell Grade at Week 8 | -0.7 units on a scale | Standard Error 0.31 |
| NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops | Anterior Chamber Cell Grade at Week 8 | -0.9 units on a scale | Standard Error 0.29 |
| Pred Forte® (1%) Ophthalmic Drops | Anterior Chamber Cell Grade at Week 8 | -0.5 units on a scale | Standard Error 0.32 |