Clinical trial NCT03004924: Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
Official title: 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 Placebo in the Treatment of Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 753
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 bacterial conjunctivitis.


Eligibility criteria: 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 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 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 \[eg,\] 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.

Primary outcomes:
measure: Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
timeFrame: Day 5
Secondary outcomes:
measure: Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
timeFrame: Baseline, Day 5
measure: Number of Participants With Clinical Resolution
timeFrame: Day 3, 8 and 12
measure: Number of Participants With Bacterial Eradication
timeFrame: Day 3, 8 and 12
measure: Bulbar Conjunctival Injection Score
timeFrame: Day 3, 5, 8 and 12
measure: Change From Baseline in the Bulbar Conjunctival Injection Score
timeFrame: Baseline, Day 3, 5, 8 and 12
measure: Ocular Conjunctival Discharge Score
timeFrame: Day 3, 5, 8 and 12
measure: Change From Baseline in the Ocular Conjunctival Discharge Score
timeFrame: Baseline, Day 3, 5, 8 and 12
measure: Global Clinical Score
timeFrame: Day 3, 5, 8 and 12
measure: Change From Baseline in the Global Clinical Score
timeFrame: Baseline, Day 3, 5, 8 and 12
measure: Number of Participants With Modified Clinical Resolution
timeFrame: Day 3, 5, 8 and 12
measure: Number of Participants With Expanded Clinical Resolution
timeFrame: Day 3, 5, 8 and 12
measure: Time to Clinical Resolution
timeFrame: Baseline to Day 12
measure: Number of Participants Who Used Rescue Medication
timeFrame: Baseline to Day 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to 14 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Prescott
country: United States
facility: M&M Eye Institute
state: Arizona
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center
state: Arizona
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO
state: California
city: Concord
country: United States
facility: Clark S Tsai Eye Center
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute Inc
state: California
city: Glendora
country: United States
facility: Mark B. Kislinger, MD, Inc.
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center
state: California
city: Lancaster
country: United States
facility: Hull Eye Center
state: California
city: Long Beach
country: United States
facility: Eye Physicians of Long Beach
state: California
city: Los Angeles
country: United States
facility: Oxford Optical
state: California
city: Los Angeles
country: United States
facility: Sok H. Nam, M.D. Inc.
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group Inc
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Poway
country: United States
facility: Arch Health Partners
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: Santa Ana
country: United States
facility: WCCT Global (PH 1 Unit)
state: California
city: Torrance
country: United States
facility: East West Eye Institute
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Parker
country: United States
facility: Specialty Eye Care
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians and Surgeons
state: Connecticut
city: Meriden
country: United States
facility: Ophthalmic Consultants of Connecticut
state: Connecticut
city: Willimantic
country: United States
facility: Windham Eye Group
state: Connecticut
city: Bradenton
country: United States
facility: The Eye Associates of Manatee, LLP
state: Florida
city: Delray Beach
country: United States
facility: Bruce A. Segal, MD, PA
state: Florida
city: Fort Lauderdale
country: United States
facility: South Florida Vision
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Miami
country: United States
facility: Millenium Clinical Research
state: Florida
city: Miami
country: United States
facility: Millennium Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: South Florida Research Center Inc.
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Miami
country: United States
facility: Lorites Medical Group
state: Florida
city: Orlando
country: United States
facility: Pediatric & Adult Research Center, LLC
state: Florida
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Score Physician Alliance, LLC
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tamarac
country: United States
facility: Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
state: Florida
city: Tamarac
country: United States
facility: Logan Ophthalmic Research, LLC
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc.
state: Georgia
city: Honolulu
country: United States
facility: Jenkins Eye Care
state: Hawaii
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Bloomingdale
country: United States
facility: Wohl Eye Center
state: Illinois
city: Lake Villa
country: United States
facility: Jackson Eye
state: Illinois
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Leawood
country: United States
facility: Sabates Eye Centers
state: Kansas
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Lexington
country: United States
facility: Koffler Vision Group
state: Kentucky
city: Lexington
country: United States
facility: Kentucky Eye Institute
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Louisville
country: United States
facility: Dr. Haider Eye Care
state: Kentucky
city: Louisville
country: United States
facility: Senior Health Services
state: Kentucky
city: Paducah
country: United States
facility: Baker, Carl W
state: Kentucky
city: Gretna
country: United States
facility: Lakeview Vision
state: Louisiana
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
state: Louisiana
city: Bangor
country: United States
facility: Eye Center Northeast
state: Maine
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Lexington
country: United States
facility: Shire Call Center
state: Massachusetts
city: Winchester
country: United States
facility: Clinical Eye Research of Boston
state: Massachusetts
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, P.A
state: Minnesota
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Saint Louis
country: United States
facility: Opthalmology Consultants Ltd.
state: Missouri
city: Springfield
country: United States
facility: Mercy Research
state: Missouri
city: Henderson
country: United States
facility: NV Eye Physicians
state: Nevada
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Las Vegas
country: United States
facility: Emil A. Stein, M.D., Ltd.
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute
state: New Jersey
city: New York
country: United States
facility: Farkas, Kassalow, Resnick &Associates
state: New York
city: Niagara Falls
country: United States
facility: Fichte, Endl& Elmer Eyecare
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care
state: New York
city: Raleigh
country: United States
facility: Oculus Research at Garner EyeCareCenter
state: North Carolina
city: Winston-Salem
country: United States
facility: James Branch, M.D.
state: North Carolina
city: Cincinnati
country: United States
facility: Apex Eye Kenwood
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cincinnati
country: United States
facility: Apex Eye
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: The Columbus Eye Center
state: Ohio
city: Westlake
country: United States
facility: SkyVision Centers
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company*
state: Oklahoma
city: Eugene
country: United States
facility: Pacific Clear Vision Institute
state: Oregon
city: Doylestown
country: United States
facility: Matossian Eye Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Wyomissing Optometric Center
state: Pennsylvania
city: Charleston
country: United States
facility: Bluestein Custom Vision
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Memphis
country: United States
facility: Eye Specialty Group
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: El Paso
country: United States
facility: Eyeland Vision
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Advanced Laser Vision & Surgical Institute
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye & Laser Center
state: Texas
city: Mission
country: United States
facility: DCT- Shah Research, LLC dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC.
state: Texas
city: Sugar Land
country: United States
facility: Lone Star Eye Care, P.A.
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development, LLC
state: Utah
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center, Inc.
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast Clinical Trials Centre
state: Queensland
city: Linz
country: Austria
facility: Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH
city: Vienna
country: Austria
facility: AKH - Medizinische Universitaet Wien
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry and Vision Science
state: Ontario
city: Tallinn
country: Estonia
facility: Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital Eye Clinic
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Limoges
country: France
facility: CHU Limoges - Hopital Dupuytren
state: Haute Vienne
city: Szeged
country: Hungary
facility: SZTE Szemeszeti Klinika
state: Csongrad
city: Gyongyos
country: Hungary
facility: Bugat Pal Hospital Clinexpert Gyongyos
state: Heves
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Kaposvár
country: Hungary
facility: Kaposi Mór Hospital
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam MC
city: Jerusalem
country: Israel
facility: Sharey Zedek MC
city: Petah Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus.
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Bologna
country: Italy
facility: A.O.U. Policlinico San'Orsola-Malpighi
city: Krakow
country: Poland
facility: Centrum Medyczne Uno-Med
state: Malopolska
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS
city: Tarnów
country: Poland
facility: Centrum Medyczne Uno-Med
city: Warszawa
country: Poland
facility: Retina Sp. z o.o.
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center, LLC
city: Carolina
country: Puerto Rico
facility: Centro Dotal de Investigaciones de Servicios de Salud
city: San Juan
country: Puerto Rico
facility: Berrocal and Associates
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Pretoria Eye Institute
state: Gauteng
city: Pretoria
country: South Africa
facility: Into Research
state: Gauteng
city: Oviedo
country: Spain
facility: Instituto Oftalmológico Fernández-Vega
state: Asturias
city: Huelva
country: Spain
facility: Clinica Oftalmologia Gil Piña
city: Madrid
country: Spain
facility: Clinica Rementeria
city: Sevilla
country: Spain
facility: Cartujavision
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: