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

NCT ID: NCT02578914

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NS2 Ophthalmic Drops (0.5%)

NS2 Ophthalmic Drops (0.5%)

Group Type: EXPERIMENTAL

NS2 Ophthalmic Drops (0.5%)

Intervention Type: DRUG

NS2 Ophthalmic Drops Vehicle (0.0%)

NS2 Ophthalmic Drops Vehicle (0.0%) control

Group Type: SHAM_COMPARATOR

NS2 Ophthalmic Drops Vehicle (0.0%)

Intervention Type: DRUG

Interventions

NS2 Ophthalmic Drops (0.5%)

Intervention Type: DRUG

NS2 Ophthalmic Drops Vehicle (0.0%)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Couroux

Role: PRINCIPAL_INVESTIGATOR

Inflamax Research Incorporated

Locations

Inflamax Research Inc.

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

15-MO-001

Identifier Type: OTHER

Identifier Source: secondary_id

ALDNS2-203-D1

Identifier Type: -

Identifier Source: org_study_id