Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
NCT ID: NCT03004924
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
753 participants
INTERVENTIONAL
2017-03-29
2018-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHP640
Participants will 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) for 7 days.
SHP640
Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
PVP-I 0.6%
Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
PVP-I 0.6%
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Placebo
Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
Placebo
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Interventions
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SHP640
Instill 1 drop of SHP640 (povidone-iodine \[PVPI\] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
PVP-I 0.6%
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Placebo
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Eligibility Criteria
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Inclusion Criteria
* 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 (ie,) greater than or equal to (\>=) 37 weeks gestational age at birth).
* Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
* Have a clinical diagnosis of suspected bacterial 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 bacterial conjunctivitis for less than or equal to (\<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of \>= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
3. Ocular conjunctival discharge: a grade of \>= 1 (mild) on a 0-3 scale of Ocular 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 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.
Exclusion Criteria
* 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 \[eg,\] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
* Have active or a 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-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
* Neonates or infants (ie, 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 (ie, 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 (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
* Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect.
* Have any known clinically significant optic nerve defects.
* Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
* Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.
* Have used any topical ocular or systemic antibiotics within \<= 7 days of enrollment.
* Have used any topical ocular non-steroidal anti-inflammatory drugs within \<= 1 day of enrollment.
* Have used any topical ophthalmic steroids in the last \<= 14 days.
* Have used any systemic corticosteroid agents within \<= 14 days of Day 1. Stable (initiated \>= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area.
* Have used non-corticosteroid immunosuppressive agents within \<= 14 days of Day 1.
* Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
* Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion.
* Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
* Within 30 days prior to the first dose of investigational product:
1. Have used an investigational product or device, or
2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Arizona Eye Center
Chandler, Arizona, United States
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
M&M Eye Institute
Prescott, Arizona, United States
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Walman Eye Center
Sun City, Arizona, United States
Milton M. Hom, OD, FAAO
Azusa, California, United States
Clark S Tsai Eye Center
Concord, California, United States
Lugene Eye Institute Inc
Glendale, California, United States
Mark B. Kislinger, MD, Inc.
Glendora, California, United States
Inland Eye Specialists
Hemet, California, United States
Lakeside Vision Center
Irvine, California, United States
Hull Eye Center
Lancaster, California, United States
Eye Physicians of Long Beach
Long Beach, California, United States
Oxford Optical
Los Angeles, California, United States
Sok H. Nam, M.D. Inc.
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Macy Eye Center
Los Angeles, California, United States
North Valley Eye Medical Group Inc
Mission Hills, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Arch Health Partners
Poway, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc.
Redding, California, United States
Clinical Trials Research
Roseville, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
WCCT Global (PH 1 Unit)
Santa Ana, California, United States
East West Eye Institute
Torrance, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Specialty Eye Care
Parker, Colorado, United States
Danbury Eye Physicians and Surgeons
Danbury, Connecticut, United States
Ophthalmic Consultants of Connecticut
Meriden, Connecticut, United States
Windham Eye Group
Willimantic, Connecticut, United States
The Eye Associates of Manatee, LLP
Bradenton, Florida, United States
Bruce A. Segal, MD, PA
Delray Beach, Florida, United States
South Florida Vision
Fort Lauderdale, Florida, United States
Bowden Eye & Associates
Jacksonville, Florida, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
Millenium Clinical Research
Miami, Florida, United States
Millennium Clinical Research, Inc.
Miami, Florida, United States
South Florida Research Center Inc.
Miami, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Lorites Medical Group
Miami, Florida, United States
Pediatric & Adult Research Center, LLC
Orlando, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Score Physician Alliance, LLC
St. Petersburg, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
Tamarac, Florida, United States
Logan Ophthalmic Research, LLC
Tamarac, Florida, United States
International Research Center
Tampa, Florida, United States
Eye Care Centers Management, Inc.
Morrow, Georgia, United States
Jenkins Eye Care
Honolulu, Hawaii, United States
Saltzer Medical Group
Nampa, Idaho, United States
Wohl Eye Center
Bloomingdale, Illinois, United States
Jackson Eye
Lake Villa, Illinois, United States
Illinois Eye Center
Peoria, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States
Sabates Eye Centers
Leawood, Kansas, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
Koffler Vision Group
Lexington, Kentucky, United States
Kentucky Eye Institute
Lexington, Kentucky, United States
The Eye Care Institute
Louisville, Kentucky, United States
Dr. Haider Eye Care
Louisville, Kentucky, United States
Senior Health Services
Louisville, Kentucky, United States
Baker, Carl W
Paducah, Kentucky, United States
Lakeview Vision
Gretna, Louisiana, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
West Monroe, Louisiana, United States
Eye Center Northeast
Bangor, Maine, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Shire Call Center
Lexington, Massachusetts, United States
Clinical Eye Research of Boston
Winchester, Massachusetts, United States
Minnesota Eye Consultants, P.A
Bloomington, Minnesota, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Moyes Eye Center
Kansas City, Missouri, United States
Mercy Research
Springfield, Missouri, United States
Washington University
St Louis, Missouri, United States
Tekwani Vision Center
St Louis, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Opthalmology Consultants Ltd.
St Louis, Missouri, United States
NV Eye Physicians
Henderson, Nevada, United States
Wellish Vision Institute
Las Vegas, Nevada, United States
Emil A. Stein, M.D., Ltd.
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Northern New Jersey Eye Institute
South Orange, New Jersey, United States
Farkas, Kassalow, Resnick &Associates
New York, New York, United States
Fichte, Endl& Elmer Eyecare
Niagara Falls, New York, United States
South Shore Eye Care
Wantagh, New York, United States
Oculus Research at Garner EyeCareCenter
Raleigh, North Carolina, United States
James Branch, M.D.
Winston-Salem, North Carolina, United States
Apex Eye Kenwood
Cincinnati, Ohio, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Apex Eye
Cincinnati, Ohio, United States
Cleveland Eye Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
The Columbus Eye Center
Columbus, Ohio, United States
SkyVision Centers
Westlake, Ohio, United States
IPS Research Company*
Oklahoma City, Oklahoma, United States
Pacific Clear Vision Institute
Eugene, Oregon, United States
Matossian Eye Associates
Doylestown, Pennsylvania, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Wyomissing Optometric Center
Wyomissing, Pennsylvania, United States
Bluestein Custom Vision
Charleston, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Eye Specialty Group
Memphis, Tennessee, United States
Nashville Vision Associates
Nashville, Tennessee, United States
Toyos Clinic
Nashville, Tennessee, United States
Eyeland Vision
El Paso, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Advanced Laser Vision & Surgical Institute
Houston, Texas, United States
Lake Travis Eye & Laser Center
Lakeway, Texas, United States
DCT- Shah Research, LLC dba Discovery Clinical Trials
Mission, Texas, United States
Sun Research Institute, LLC
San Antonio, Texas, United States
R and R Eye Research, LLC.
San Antonio, Texas, United States
Lone Star Eye Care, P.A.
Sugar Land, Texas, United States
Ericksen Research & Development, LLC
Clinton, Utah, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Piedmont Eye Center, Inc.
Lynchburg, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of the Sunshine Coast Clinical Trials Centre
Sippy Downs, Queensland, Australia
Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH
Linz, , Austria
AKH - Medizinische Universitaet Wien
Vienna, , Austria
Vienna Institute for Research in Ocular Surgery
Vienna, , Austria
The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
Ottawa, Ontario, Canada
University of Waterloo School of Optometry and Vision Science
Waterloo, Ontario, Canada
Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)
Tallinn, , Estonia
East Tallinn Central Hospital Eye Clinic
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
CHU Limoges - Hopital Dupuytren
Limoges, Haute Vienne, France
SZTE Szemeszeti Klinika
Szeged, Csongrád megye, Hungary
Bugat Pal Hospital Clinexpert Gyongyos
Gyöngyös, Heves County, Hungary
Debreceni Egyetem
Debrecen, , Hungary
Kaposi Mór Hospital
Kaposvár, , Hungary
Csolnoky Ferenc Korhaz
Veszprém, , Hungary
HaEmek Medical Center
Afula, , Israel
Soroka University Medical Center
Beersheba, , Israel
Rambam MC
Haifa, , Israel
Sharey Zedek MC
Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus.
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Medical Center
Tel Aviv, , Israel
A.O.U. Policlinico San'Orsola-Malpighi
Bologna, , Italy
Centrum Medyczne Uno-Med
Krakow, Malopolska, Poland
Szpital Specjalistyczny nr 1
Bytom, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, , Poland
Centrum Medyczne Uno-Med
Tarnów, , Poland
Retina Sp. z o.o.
Warsaw, , Poland
Emanuelli Research & Development Center, LLC
Arecibo, , Puerto Rico
Centro Dotal de Investigaciones de Servicios de Salud
Carolina, , Puerto Rico
Berrocal and Associates
San Juan, , Puerto Rico
Newtown Clinical Research Centre
Johannesburg, Gauteng, South Africa
Pretoria Eye Institute
Pretoria, Gauteng, South Africa
Into Research
Pretoria, Gauteng, South Africa
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias, Spain
Clinica Oftalmologia Gil Piña
Huelva, , Spain
Clinica Rementeria
Madrid, , Spain
Cartujavision
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003361-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP640-303
Identifier Type: -
Identifier Source: org_study_id
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