Clinical trial NCT02578914: A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
Official title: A Randomized, Parallel, Single-Center, Double-Masked, Vehicle-Controlled Phase II Study to Evaluate the Activity of NS2 Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Provocation Test (CAPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Seasonal Allergies
Keywords: allergic conjunctivitis
seasonal allergies
ragweed allergy
grass allergy
tree allergy
NS2
Aldeyra
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
timeFrame: The efficacy assessment period was assessed at Day 14; baseline was Day -7.
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Inflamax Research Inc.
state: Ontario
Study officials:
affiliation: Inflamax Research Incorporated
name: Peter Couroux
role: PRINCIPAL_INVESTIGATOR
References: