A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
Condition: Allergic Conjunctivitis; Seasonal Allergies
MeSH terms: Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Intervention: NS2 Ophthalmic Drops (0.5%); NS2 Ophthalmic Drops Vehicle (0.0%)
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: allergic conjunctivitis; seasonal allergies; ragweed allergy; grass allergy; tree allergy; NS2; Aldeyra

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.