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

Phase 2CompletedNCT03320434

ORA, Inc.120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Allergic Conjunctivitis

Interventions

PRT-2761 0.5%DRUG

Six drops in each eye over a 17 day period.

PRT-2761 1%DRUG

Six drops in each eye over a 17 day period.

PatanolDRUG

Six drops in each eye over a 17 day period.

Pred-forte

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

Data from ClinicalTrials.gov

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