NCT03320434

Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	PRT-2761 0.5%	Six drops in each eye over a 17 day period.
DRUG	PRT-2761 1%	Six drops in each eye over a 17 day period.
DRUG	Patanol	Six drops in each eye over a 17 day period.
DRUG	Pred-forte	Four drops in each eye over a 3 day period.
DRUG	PRT-2761 0%	Six drops in each eye over a 17 day period.

Timeline

• Start date: 2017-10-13
• Primary completion: 2018-02-16
• Completion: 2018-02-18
• First posted: 2017-10-25
• Last updated: 2022-10-17
• Results posted: 2022-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study