Skip to main content
OpenTrials
Completed

NCT Number: NCT03320434

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Patanol

Drug

Six drops in each eye over a 17 day period.

Pred-forte

Drug

Four drops in each eye over a 3 day period.

PRT-2761 0%

Drug

Six drops in each eye over a 17 day period.

Primary outcomes

  1. Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1

    Time frame: post CAC exposure 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.

  2. Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15

    Time frame: post CAC exposure 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.

  3. Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1

    Time frame: post CAC exposure 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.

  4. 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.

    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.

Sponsors and collaborators

Lead sponsor

ORA, Inc.

Industry

Registry information

Official study title

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®)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2017
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.