NCT03368339

Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis

Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle of PR013 Topical Ophthalmic Drops for the Treatment of Allergic Conjunctivitis Using Conjunctival Allergen Challenge Model (Ora-CAC®)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Realm Therapeutics, Inc. · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).

Detailed description

A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of PR013 Topical Ophthalmic Drops (0.045% and 0.06%) Compared to Vehicle of PR013 Topical Ophthalmic Drops for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	PR013 (0.045%)	PR013 topical Ophthalmic Drops (0.045%)
DRUG	PR013 (0.06%)	PR013 topical Ophthalmic Drops (0.06%)
DRUG	Vehicle	Vehicle

Timeline

• Start date: 2017-12-10
• Primary completion: 2018-01-21
• Completion: 2018-01-28
• First posted: 2017-12-11
• Last updated: 2020-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study