A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aldeyra Therapeutics, Inc.
• Treatments: Ophthalmic Solutions

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.