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

NCT ID: NCT03320434

Last Updated: 2022-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2018-02-18

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PRT-2761 0.5%

Group Type EXPERIMENTAL

PRT-2761 0.5%

Intervention Type DRUG

Six drops in each eye over a 17 day period.

PRT-2761 1%

Group Type EXPERIMENTAL

PRT-2761 1%

Intervention Type DRUG

Six drops in each eye over a 17 day period.

Patanol

Group Type ACTIVE_COMPARATOR

Patanol

Intervention Type DRUG

Six drops in each eye over a 17 day period.

Pred-forte

Group Type ACTIVE_COMPARATOR

Pred-forte

Intervention Type DRUG

Four drops in each eye over a 3 day period.

PRT-2761 0%

Group Type PLACEBO_COMPARATOR

PRT-2761 0%

Intervention Type DRUG

Six drops in each eye over a 17 day period.

Interventions

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PRT-2761 0.5%

Six drops in each eye over a 17 day period.

Intervention Type DRUG

PRT-2761 1%

Six drops in each eye over a 17 day period.

Intervention Type DRUG

Patanol

Six drops in each eye over a 17 day period.

Intervention Type DRUG

Pred-forte

Four drops in each eye over a 3 day period.

Intervention Type DRUG

PRT-2761 0%

Six drops in each eye over a 17 day period.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ORA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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17-100-0008

Identifier Type: -

Identifier Source: org_study_id

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