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

NCT02998541 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: SHP640-3012016-002439-14
• Study Type: interventional
• Target: 219
• Locations: 14 countries
• Sites: 119

Brief 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.

Conditions

Adenoviral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo 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. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. 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). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

  Day 6

Secondary Outcomes (15)

• Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6

  Day 6

• Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6

  Day 6

• Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3

  Day 3

• Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6

  Day 6

• Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6

  Day 6

Study Arms (3)

SHP640

EXPERIMENTAL

Participants will receive one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

Drug: SHP640

PVP-I 0.6%

ACTIVE COMPARATOR

Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.

Drug: PVP-I 0.6%

Placebo

PLACEBO COMPARATOR

Participants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days.

Other: Placebo

Interventions

SHP640 DRUG

Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.

Also known as: FST-100

SHP640

PVP-I 0.6% DRUG

Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

PVP-I 0.6%

Placebo OTHER

Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) 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 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.
• 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 lesser than or equal to (\<=) 4 days prior to Visit 1
• Bulbar conjunctival injection: a grade of \>= 1 (mild) on a 0-4 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 AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker 2016; American Academy of Pediatrics 2016).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 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.
• 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 (e.g. bacterial, fungal, acanthamoebal, or other parasitic).
• Neonates or infants (i.e. participants less than 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 (i.e. participants less than 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 (e.g. 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 (130)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

Midwestern University Eye Institute

Glendale, Arizona, 85308, United States

Location

M&M Eye Institute

Prescott, Arizona, 86301, United States

Location

Walman Eye Center

Sun City, Arizona, 85351, United States

Location

Milton M. Hom, OD, FAAO

Azusa, California, 91702, United States

Location

Mark B. Kislinger, MD, PhD, Inc.

Glendora, California, 91741, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

Lakeside Vision Center

Irvine, California, 92604, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Eye Physicians of Long Beach

Long Beach, California, 90808, United States

Location

Oxford Optical

Los Angeles, California, 90020, United States

Location

Macy Eye Center

Los Angeles, California, 90048, United States

Location

Shultz Chang Vision

Northridge, California, 91325, United States

Location

Stanford Byers Eye Institute

Palo Alto, California, 94303, United States

Location

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

Arch Health Partners

Poway, California, 92064, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Shasta Eye Medical Group, Inc.

Redding, California, 96002, United States

Location

The Eye Associates

Bradenton, Florida, 34209, United States

Location

South Florida Vision Associates, LLC

Fort Lauderdale, Florida, 33309, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Lorites Medical Group

Miami, Florida, 33166, United States

Location

Pediatric & Adult Research Center, LLC

Orlando, Florida, 32825, United States

Location

East Florida Eye Institute

Stuart, Florida, 34494, United States

Location

Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC

Tamarac, Florida, 33321, United States

Location

Eye Care Centers Management, Inc.

Morrow, Georgia, 30260, United States

Location

Jackson Eye

Lake Villa, Illinois, 60046, United States

Location

Illinois Eye Center

Peoria, Illinois, 61615, United States

Location

MediSphere Medical Research Center, an AMR affiliate

Evansville, Indiana, 47714, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Koffler Vision Group

Lexington, Kentucky, 40509, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Senior Health Services

Louisville, Kentucky, 40220, United States

Location

Baker, Carl W

Paducah, Kentucky, 42001, United States

Location

Lakeview Vision - Gretna

Gretna, Louisiana, 70056, United States

Location

Haik Humble Eye Center

West Monroe, Louisiana, 71291, United States

Location

Eye Center Northeast

Bangor, Maine, 04401, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Shire Call Center

Lexington, Massachusetts, 02421, United States

Location

Clinical Eye Research of Boston

Winchester, Massachusetts, 02114, United States

Location

The Regents of the University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Minnesota Eye Consultants, P.A.

Bloomington, Minnesota, 55431, United States

Location

Lifelong Vision Foundation

Chesterfield, Missouri, 63017, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Mercy Research

Springfield, Missouri, 65806, United States

Location

Nevada Eye Care Professionals

Las Vegas, Nevada, 89129, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079, United States

Location

Oculus Research

Raleigh, North Carolina, 27603, United States

Location

James Branch, M.D.

Winston-Salem, North Carolina, 27101, United States

Location

Matossian Eye Associates

Doylestown, Pennsylvania, 18902, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Wyomissing Optometric Center

Wyomissing, Pennsylvania, 19610, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 59101, United States

Location

The Eye Center at Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Nashville Vision Associates

Nashville, Tennessee, 37205, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Lake Travis Eye & Laser Center

Lakeway, Texas, 78734, United States

Location

Houston Eye Associates

League City, Texas, 77573, United States

Location

DCT-Shah Research, LLC dba Discovery Clinical Trials

Mission, Texas, 78572, United States

Location

R and R Eye Research, LLC.

San Antonio, Texas, 78229, United States

Location

Lone Star Eye Care, P.A.

Sugar Land, Texas, 77479, United States

Location

Ericksen Research & Development, LLC

Clinton, Utah, 84015, United States

Location

Emerson Clinical Research Institute, LLC

Falls Church, Virginia, 22046, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

University of the Sunshine Coast Clinical Trials Centre

Sippy Downs, Queensland, 4556, Australia

Location

Kepler Universitätsklinikum

Linz, 4020, Austria

Location

AKH - Medizinische Universitaet Wien

Vienna, 1090, Austria

Location

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

The Ottawa Hospital - General Campus, University of Ottawa Eye Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University of Waterloo School of Optometry and Vision Science

Waterloo, Ontario, N2L 3G1, Canada

Location

McGill University Health Centre/Glen Site / Royal Victoria Hospital

Montreal, Quebec, H4A 3S5, Canada

Location

Eye Clinic Dr Kirsta Turman

Tallinn, 10120, Estonia

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

Tartu University Hospital

Tartu, 51010, Estonia

Location

CHU Limoges - Hopital Dupuytren

Limoges, Haute Vienne, 87042, France

Location

Hopital Necker - Enfants Malades

Paris, 75015, France

Location

Klinisches Studienzentrum der Augenklinik

Mainz, 55131, Germany

Location

Augenärzte am Franziskus Hospital

Münster, 48145, Germany

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád megye, 6720, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, Heves County, 3200, Hungary

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Csolnoky Ferenc Korhaz

Veszprém, 8200, Hungary

Location

L. V. Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500034, India

Location

Sankara Eye Hospital

Bangalore, Karnataka, 560037, India

Location

Bhagwan Mahaveer Jain Hospital

Bangalore, Karnataka, 560052, India

Location

M. S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, 560054, India

Location

Sapthagiri Hospital

Bangalore, Karnataka, 560090, India

Location

K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

NKP Salve Institute of Medical Sciences

Nagpur, Maharashtra, 440025, India

Location

Dr. D. Y. Patil Medical College

Navi Mumbai, Maharashtra, 400706, India

Location

PBMA'S H. V. Desai Eye Hospital

Pune, Maharashtra, 411060, India

Location

S. P. Medical College & Associated Group of Hospitals

Bikaner, Rajasthan, 334003, India

Location

ICARE Eye Hospital and Post Graduate Institute

Noida, Uttar Pradesh, 201301, India

Location

Regional Institute of Ophthalmology

Kolkata, West Bengal, 700073, India

Location

HaEmek Medical Center

Afula, 18341, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam MC

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Rabin Medical Center-Beilinson Campus

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

A.O.U. Policlinico San'Orsola-Malpighi

Bologna, 40138, Italy

Location

Instituto Regional de Oftalmología

La Libertad, 13007, Peru

Location

Macula D&T S.R.L.

Lima, 27, Peru

Location

Oftalmosalud SRL.

Lima, 27, Peru

Location

Szpital Specjalistyczny nr 1

Bytom, 41-902, Poland

Location

Centrum Medyczne UNO-MED

Krakow, 31-070, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424, Poland

Location

Centrum Medyczne Uno-Med (Private Practice)

Tarnów, 33-100, Poland

Location

Retina Sp. z o.o.

Warsaw, 01 -364, Poland

Location

Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa

Location

Into Research

Pretoria, Gauteng, 0181, South Africa

Location

Pretoria Eye Institute Research Foundation

Pretoria, Gauteng, 83, South Africa

Location

Nelson R Mandela School of Medicine Ophthalmology Department

Durban, KwaZulu-Natal, 4001, South Africa

Location

Instituto Oftalmológico Fernández-Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Complejo Asistencial Universitario de Burgos

Burgos, 9006, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17001, Spain

Location

Clinica Oftalmologia Gil Piña

Huelva, 21002, Spain

Location

Clinica Rementeria

Madrid, 28010, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Cartuja Vision

Seville, 41092, Spain

Location

FISABIO-Oftalmología Médica

Valencia, 46015, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Manchester Royal Eye Hospital

Manchester, Greater Manchester, M139WL, United Kingdom

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 27, 2017
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: June 14, 2021
• Results First Posted: May 27, 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

PL (5); FR (2); GB (1); DE (2); IN (12); CA (3); US (68); IT (1); ZA (4); ES (3); IL (7); HU (5); AU (3); PE (3)