NCT02578914

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	NS2 Ophthalmic Drops (0.5%)
DRUG	NS2 Ophthalmic Drops Vehicle (0.0%)

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-10-19
• Last updated: 2023-12-05
• Results posted: 2023-12-05

Locations

1 site across 1 country: Canada