Phase 2
N=100
A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
Allergic Conjunctivitis · Seasonal Allergies
Bottom Line
View on ClinicalTrials.gov: NCT02578914 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge — -1.550; -1.013 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NS2 Ophthalmic Drops (0.5%) (Drug); NS2 Ophthalmic Drops Vehicle (0.0%) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge |
-1.550; -1.013 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02578914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.