Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo

NCT02998554 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: SHP640-3022016-002440-16
• Study Type: interventional
• Target: 156
• Locations: 2 countries
• Sites: 31

Brief Summary

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.

Conditions

Adenoviral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Resolution on Day 6

  Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.

  Day 6

Secondary Outcomes (11)

• Percentage of Participants With Adenoviral Eradication on Day 6

  Day 6

• Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8

  Day 6 and 8

• Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)

  Day 3, 8 and 12/ET

• Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)

  Day 3, 8 and 12/ET

• Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)

  Day 3, 6, 8 and 12/ET

Study Arms (2)

SHP640

EXPERIMENTAL

Participants instructed to instill 1 drop of SHP640 (Povidone-iodine \[PVP-I\] 0.6 percent \[%\] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.

Drug: SHP640

Placebo

PLACEBO COMPARATOR

Participants instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

Drug: Placebo

Interventions

SHP640 DRUG

Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.

SHP640

Placebo DRUG

Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 less than (\<) 3 months of age at Visit 1 must have been full-term, that is 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 (example: 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 1 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.
• 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: Report presence of signs and/or symptoms of adenoviral conjunctivitis for less than or equal to (\<=) 4 days prior to Visit 1; Bulbar conjunctival injection: a grade of \>=1 on 0-4 scale of Bulbar Conjunctival Injection Scale; Watery conjunctival discharge: a grade of \>=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale.
• Be willing to discontinue contact lens wear for the duration of the study.
• Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the American Academy of Pediatrics (AAP) Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians. The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants \< 2 months of age who have not yet developed this ability. Participants \< 2 months will be enrolled at the discretion of the investigator.
• Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

You may not qualify if:

• 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 participant 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 preplanned overnight hospitalization during the period of the study.
• Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example: 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.
• Have at enrollment or within \<= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-adenoviral ocular infection (example: bacterial, fungal, acanthamoebal, or other parasitic).
• Neonates or infants (that is (ie,) participants \< 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
• Neonates or infants (ie, participants \< 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
• Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
• Presence of any significant ophthalmic condition (example: retinopathy of prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.

Sponsors & Collaborators

• Shire: lead

Study Sites (31)

Lugene Eye Institute Inc

Glendale, California, 91204, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Danbury Eye Physicians and Surgeons

Danbury, Connecticut, 06810, United States

Location

Bruce A. Segal, MD, PA

Delray Beach, Florida, 33484, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32256, United States

Location

Shettle Eye Research, Inc.

Largo, Florida, 33773, United States

Location

South Florida Research Center Inc.

Miami, Florida, 33135, United States

Location

International Research Center

Tampa, Florida, 33603, United States

Location

Saltzer Medical Group

Nampa, Idaho, 83686, United States

Location

Sabates Eye Centers

Leawood, Kansas, 40004, United States

Location

Physicians to Children & Adolescents

Bardstown, Kentucky, 40004, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Shire Call Center

Lexington, Massachusetts, 02421, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Wellish Vision Institute

Las Vegas, Nevada, 89119, United States

Location

Fichte, Endl and Elmer Eyecare

Niagara Falls, New York, 14304, United States

Location

Apex Eye Kenwood

Cincinnati, Ohio, 45236, United States

Location

Cleveland Eye Clinic

Cleveland, Ohio, 44141, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73120, United States

Location

Eyeland Vision

El Paso, Texas, 79934, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Sun Research Institute, LLC

San Antonio, Texas, 78215, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84117, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Piedmont Eye Center, Inc.

Lynchburg, Virginia, 24502, United States

Location

Emanuelli Research & Development Center, LLC

Arecibo, 00613, Puerto Rico

Location

University Of Puerto Rico, School of Medicine

Carolina, 00984, Puerto Rico

Location

Limitations and Caveats

The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: March 28, 2017
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: June 9, 2021
• Results First Posted: May 29, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (29); PR (2)