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

NCT02578914 | Completed Phase 2 Results

• 2 other identifiers: ALDNS2-203-D115-MO-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis; Seasonal Allergies

Keywords

allergic conjunctivitis; seasonal allergies; ragweed allergy; grass allergy; tree allergy; NS2; Aldeyra

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

NS2 Ophthalmic Drops (0.5%)

EXPERIMENTAL

NS2 Ophthalmic Drops (0.5%)

Drug: NS2 Ophthalmic Drops (0.5%)

NS2 Ophthalmic Drops Vehicle (0.0%)

SHAM COMPARATOR

NS2 Ophthalmic Drops Vehicle (0.0%) control

Drug: NS2 Ophthalmic Drops Vehicle (0.0%)

Interventions

NS2 Ophthalmic Drops (0.5%) DRUG

NS2 Ophthalmic Drops (0.5%)

NS2 Ophthalmic Drops Vehicle (0.0%) DRUG

NS2 Ophthalmic Drops Vehicle (0.0%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Inflamax Research Inc.

Mississauga, Ontario, L4W 1A4, Canada

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Study Officials

• Peter Couroux

  Inflamax Research Incorporated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 19, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2016-05

Locations

CA (1)