Allergic Conjunctivitis Clinical Trial
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)
Verified date | May 2016 |
Source | Aldeyra Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Inflamax Research Inc. | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Aldeyra Therapeutics, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | The efficacy assessment period was assessed at Day 14; baseline was Day -7. |
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