Now Recruiting

Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo

WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.

TRIAL AT A GLANCE

Condition

Adenoviral Conjunctivitis

Study Intervention

SHP640; Placebo

Possibility of Active Treatment

50%

Study Type

Interventional

Phase

Phase 3

IS THIS STUDY RIGHT FOR ME?

AGE

N/A

N/A

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

Participation will consist of up to 5 visits to the study site over a period of up to 13 days. Enrolled patients will be randomly assigned to receive either the investigational treatment or placebo in a ratio of 1:1. Multiple patients from the same household will be eligible to participate in the study (up to a prespecified household cap). Patients from the same household will be assigned to the same treatment group.Patients who are randomized into the trial will receive the first dose of the assigned treatment on Day 1. All following doses will be administered by the patient or caregiver in both eyes 4 times per day for 7 days.

ENTRY CRITERIA

Must test positive for adenoviral conjunctivitis in at least 1 eye (via the RPS AdenoPlus® test at Visit 1)

Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (thesame eye as the RPS AdenoPlus® positive eye)

Must be willing to discontinue contact lens wear for the duration of the study

Cannot have a known or suspected intolerance or hypersensitivity to the investigationalproduct, closely related compounds, or any of the stated ingredients

Cannot have previously enrolled in a FST-100 or SHP640 clinical study

Cannot have had ocular surgical intervention within ≤ 6 months prior to Visit 1 orplanned for the period of the study

Cannot have active or history of ocular herpes

Cannot have clinical signs of ocular allergy or an ocular infection (e.g., bacterial,acanthamoeba, fungal or other ocular viral infection) currently or within ≤ 30 days ofVisit 1 other than adenoviral conjunctivitis

Study Locations

We are planning* on conducting this study in 2 countries around the world.

    • Puerto Rico
    • United States of America

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RESULTS

*Planning is an intent to conduct this study in the specified countries and is subject to change.