CompletedPhase 2

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

Canada100 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 as…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT02578914

SponsorAldeyra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12

Results submitted2023-02-27

View on ClinicalTrials.gov More Allergic Conjunctivitis trials