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

Phase 2

Completed

• Conditions: Seasonal Allergies; Allergic Conjunctivitis
• Interventions: Drug: NS2 Ophthalmic Drops (0.5%); Drug: NS2 Ophthalmic Drops Vehicle (0.0%)

• Registration Number: NCT02578914
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Results First Submitted: 2023-02-27
• Results First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Results First Posted: 2023-12-05
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NS2 Ophthalmic Drops (0.5%)	NS2 Ophthalmic Drops (0.5%)	NS2 Ophthalmic Drops (0.5%)
NS2 Ophthalmic Drops Vehicle (0.0%)	NS2 Ophthalmic Drops Vehicle (0.0%)	NS2 Ophthalmic Drops Vehicle (0.0%) control

Primary Outcome Measures

Name	Time	Method
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge	The efficacy assessment period was assessed at Day 14; baseline was Day -7.	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.

Trial Locations

Locations (1)

Inflamax Research Inc.; 🇨🇦 Mississauga, Ontario, Canada