NCT02978183

Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.

Detailed description

The study is a multi-center, double-masked, randomized, placebo-controlled, modified conjunctival allergen challenge (CAC) model. The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subject's final visit. Subjects who meet inclusion criteria will be randomized to one of two treatment groups (1:1). Randomization will be stratified by average post-CAC itching scores at baseline. Subjects will be evaluated at baseline and on Days 6, 7 and 8.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	ST266	One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
DRUG	Saline (0.9% NaCl)	One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-02-01
• Completion: 2017-11-01
• First posted: 2016-11-30
• Last updated: 2023-04-10
• Results posted: 2021-09-16

Locations

2 sites across 1 country: United States