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®)

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: PRT-2761 0.5%; Drug: PRT-2761 1%; Drug: Patanol; Drug: Pred-forte; Drug: PRT-2761 0%

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• be at least 18 years old
• be willing and able to avoid all disallowed medications and contact lenses
• must have a pregnancy test if of childbearing potential
• must be able to read an eye chart from 10 feet away

Exclusion Criteria:

• must not have any allergies to the study medications
• must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
• must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRT-2761 0.5%	Drug: PRT-2761 0.5%; Six drops in each eye over a 17 day period.
Experimental: PRT-2761 1%	Drug: PRT-2761 1%; Six drops in each eye over a 17 day period.
Active Comparator: Patanol	Drug: Patanol; Six drops in each eye over a 17 day period.
Active Comparator: Pred-forte	Drug: Pred-forte; Four drops in each eye over a 3 day period.
Placebo Comparator: PRT-2761 0%	Drug: PRT-2761 0%; Six drops in each eye over a 17 day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1	Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.	post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15	Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.	post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1	Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.	post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15	Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.	post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

Collaborators and Investigators

• Sponsor: ORA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Actual): February 16, 2018
• Study Completion (Actual): February 18, 2018

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 17-100-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No