Allergic Conjunctivitis, Seasonal Allergies
Conditions
Keywords
allergic conjunctivitis, seasonal allergies, ragweed allergy, grass allergy, tree allergy, NS2, Aldeyra
Brief summary
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%). Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.
Interventions
DRUGNS2 Ophthalmic Drops (0.5%)
DRUGNS2 Ophthalmic Drops Vehicle (0.0%)
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of \>2 * Graded ocular itching at any one time point * Visual acuity of at least 20/50 in each eye * At least 2 year history of moderate to severe allergic conjunctivitis. * Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1). * Ability to avoid any topical or systemic ocular medications during the entire study period.
Exclusion criteria
* Subjects must not have an ocular itching score \>0 or a conjunctival redness score \>1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I * History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year. * Ocular surgery, including laser procedures, within the past 12 months of Visit 1. * Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit. * History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis. * History of uveitis in the past 3 years. * Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1). * History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT. * Use of oral corticosteroids within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period. * Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge | The efficacy assessment period was assessed at Day 14; baseline was Day -7. | Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. 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
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NS2 Ophthalmic Drops (0.5%) NS2 administered QID for approximately 2 weeks | 50 |
| Vehicle Ophthalmic Drops Vehicle administered QID for approximately 2 weeks | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | NS2 Ophthalmic Drops (0.5%) | Vehicle Ophthalmic Drops | Total |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 12.5 | 41.9 years STANDARD_DEVIATION 12.1 | 43.5 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 45 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 9 Participants | 22 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants | 8 Participants | 19 Participants |
| Race/Ethnicity, Customized Native Hawaiian / other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 30 Participants | 52 Participants |
| Region of Enrollment Canada | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 32 Participants | 24 Participants | 56 Participants |
| Sex: Female, Male Male | 18 Participants | 26 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 49 / 50 | 11 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. 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 Day 14; baseline was Day -7.
Population: Intent-to-treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge | -1.550 units on a scale | Standard Error 0.168 |
| Vehicle Ophthalmic Drops | Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge | -1.013 units on a scale | Standard Error 0.163 |