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Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

NCT02998541•Shire

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
•Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
•Participants of any age at Visit 1 (Note: participants lesser than (\<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (\>=) 37 weeks gestational age at birth).
•Meet at least 1 of the 2 criteria below:
•a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc).
•ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.
•iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.
•Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
•1. Report presence of signs and/or symptoms of adenoviral conjunctivitis for lesser than or equal to (\<=) 4 days prior to Visit 1
•2. Bulbar conjunctival injection: a grade of \>= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
+5 more criteria

Exclusion Criteria

•Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
•Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participants unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
•Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
•Prior enrollment in a FST-100 or SHP640 clinical study.
•Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
•Have a history of ocular surgical intervention within \<= 6 months prior to Visit 1 or planned for the period of the study.
•Have a pre-planned overnight hospitalization during the period of the study.
•Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
•Have presence of corneal subepithelial infiltrates at Visit 1.
•Have active or history of ocular herpes.
+21 more criteria

Locations (130)

Arizona Eye Center

Chandler, Arizona, United States

Midwestern University Eye Institute

Glendale, Arizona, United States

M&M Eye Institute

Prescott, Arizona, United States

Walman Eye Center

Sun City, Arizona, United States

Milton M. Hom, OD, FAAO

Azusa, California, United States

Mark B. Kislinger, MD, PhD, Inc.

Glendora, California, United States

Inland Eye Specialists

Hemet, California, United States

Lakeside Vision Center

Irvine, California, United States

Loma Linda University

Loma Linda, California, United States

Eye Physicians of Long Beach

Long Beach, California, United States

Key Dates

Start Date

March 27, 2017

Primary Completion Date

May 13, 2019

Completion Date

May 13, 2019

Last Updated

June 14, 2021

Enrollment

219

ACTUAL participants

Conditions

Adenoviral Conjunctivitis

Interventions

SHP640

DRUG

PVP-I 0.6%

DRUG

Placebo

OTHER

Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis

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Adenoviral Conjunctivitis

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COMPLETEDNA

Reducing Adenoviral Patient Infected Days

NCT02472223

ConjunctivitisAdenoviral Conjunctivitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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