AzTrials
AzTrials

Bacterial ConjunctivitisPhase 3NCT03004924

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

A Phase 3 study testing SHP640 and PVP-I 0.6% in people with Bacterial Conjunctivitis, run by Shire at 163 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Bacterial Conjunctivitis
What is being tested?
SHP640 and PVP-I 0.6%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
753 participants
Where
163 sitesin 13 countries
Study dates
29 Mar 2017to 1 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
  • Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1
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  • Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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:
  • Have used an investigational product or device, or
  • Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.

Trial locations and contacts

163 sites in 13 countries.

163 sites in 13 countries

United States125 sites

  • Milton M. Hom, OD, FAAO

    Azusa, California, 91702

  • Eye Center Northeast

    Bangor, Maine, 04401

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Wohl Eye Center

    Bloomingdale, Illinois, 60108

  • Minnesota Eye Consultants, P.A

    Bloomington, Minnesota, 55431

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • The Eye Associates of Manatee, LLP

    Bradenton, Florida, 34209

  • Arizona Eye Center

    Chandler, Arizona, 85225

  • Bluestein Custom Vision

    Charleston, South Carolina, 29414

  • Lifelong Vision Foundation

    Chesterfield, Missouri, 63017

  • Apex Eye Kenwood

    Cincinnati, Ohio, 45236

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Apex Eye

    Cincinnati, Ohio, 45247

  • Cleveland Eye Clinic

    Cleveland, Ohio, 44141

  • Ericksen Research & Development, LLC

    Clinton, Utah, 84015

  • The Ohio State University

    Columbus, Ohio, 43210

  • The Columbus Eye Center

    Columbus, Ohio, 43215

  • Clark S Tsai Eye Center

    Concord, California, 94520

  • Danbury Eye Physicians and Surgeons

    Danbury, Connecticut, 06810

  • Bruce A. Segal, MD, PA

    Delray Beach, Florida, 33484

  • Matossian Eye Associates

    Doylestown, Pennsylvania, 18902

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • Eyeland Vision

    El Paso, Texas, 79934

  • Pacific Clear Vision Institute

    Eugene, Oregon, 97401

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 22046

  • South Florida Vision

    Fort Lauderdale, Florida, 33309

  • Lugene Eye Institute Inc

    Glendale, California, 91204

  • Mark B. Kislinger, MD, Inc.

    Glendora, California, 91741

  • Lakeview Vision

    Gretna, Louisiana, 70056

  • Inland Eye Specialists

    Hemet, California, 92545

  • NV Eye Physicians

    Henderson, Nevada, 89074

  • Jenkins Eye Care

    Honolulu, Hawaii, 96814

  • Houston Eye Associates

    Houston, Texas, 77025

  • Advanced Laser Vision & Surgical Institute

    Houston, Texas, 77034

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana, 46290

  • Lakeside Vision Center

    Irvine, California, 92604

  • Bowden Eye & Associates

    Jacksonville, Florida, 32256

  • Silverstein Eye Centers

    Kansas City, Missouri, 64133

  • Moyes Eye Center

    Kansas City, Missouri, 64154

  • Jackson Eye

    Lake Villa, Illinois, 60046

  • Lake Travis Eye & Laser Center

    Lakeway, Texas, 78734

  • Hull Eye Center

    Lancaster, California, 93534

  • Shettle Eye Research, Inc.

    Largo, Florida, 33773

  • Wellish Vision Institute

    Las Vegas, Nevada, 89119

  • Emil A. Stein, M.D., Ltd.

    Las Vegas, Nevada, 89129

  • Sabates Eye Centers

    Leawood, Kansas, 66211

  • Koffler Vision Group

    Lexington, Kentucky, 40509

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517

  • Shire Call Center

    Lexington, Massachusetts, 02421

  • Eye Physicians of Long Beach

    Long Beach, California, 90808

  • Oxford Optical

    Los Angeles, California, 90020

  • Sok H. Nam, M.D. Inc.

    Los Angeles, California, 90020

  • University of Southern California

    Los Angeles, California, 90033

  • Macy Eye Center

    Los Angeles, California, 90048

  • The Eye Care Institute

    Louisville, Kentucky, 40206

  • Dr. Haider Eye Care

    Louisville, Kentucky, 40220

  • Senior Health Services

    Louisville, Kentucky, 40220

  • Piedmont Eye Center, Inc.

    Lynchburg, Virginia, 24502

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Total Eye Care, PA

    Memphis, Tennessee, 38119

  • Eye Specialty Group

    Memphis, Tennessee, 38120

  • Ophthalmic Consultants of Connecticut

    Meriden, Connecticut, 06824

  • Millenium Clinical Research

    Miami, Florida, 33125

  • Millennium Clinical Research, Inc.

    Miami, Florida, 33125

  • South Florida Research Center Inc.

    Miami, Florida, 33135

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Lorites Medical Group

    Miami, Florida, 33166

  • DCT- Shah Research, LLC dba Discovery Clinical Trials

    Mission, Texas, 78572

  • North Valley Eye Medical Group Inc

    Mission Hills, California, 91345

  • Eye Care Centers Management, Inc.

    Morrow, Georgia, 30260

  • Saltzer Medical Group

    Nampa, Idaho, 83686

  • Nashville Vision Associates

    Nashville, Tennessee, 37205

  • Toyos Clinic

    Nashville, Tennessee, 37215

  • Farkas, Kassalow, Resnick &Associates

    New York, New York, 10022

  • Fichte, Endl& Elmer Eyecare

    Niagara Falls, New York, 14304

  • IPS Research Company*

    Oklahoma City, Oklahoma, 73120

  • Pediatric & Adult Research Center, LLC

    Orlando, Florida, 32825

  • Baker, Carl W

    Paducah, Kentucky, 42001

  • Specialty Eye Care

    Parker, Colorado, 80134

  • Illinois Eye Center

    Peoria, Illinois, 61615

  • North Bay Eye Associates, Inc.

    Petaluma, California, 94954

  • Philadelphia Eye Associates

    Philadelphia, Pennsylvania, 19148

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona, 85032

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • UPMC Eye Center

    Pittsburgh, Pennsylvania, 15213

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33948

  • Arch Health Partners

    Poway, California, 92064

  • M&M Eye Institute

    Prescott, Arizona, 86301

  • Oculus Research at Garner EyeCareCenter

    Raleigh, North Carolina, 27603

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 59101

  • Shasta Eye Medical Group, Inc.

    Redding, California, 96001

  • Clinical Trials Research

    Roseville, California, 95661

  • Sacramento Eye Consultants

    Sacramento, California, 95815

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

  • Jean Brown Research

    Salt Lake City, Utah, 84117

  • Sun Research Institute, LLC

    San Antonio, Texas, 78215

  • R and R Eye Research, LLC.

    San Antonio, Texas, 78229

  • WCCT Global (PH 1 Unit)

    Santa Ana, California, 92705

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260

  • Northern New Jersey Eye Institute

    South Orange, New Jersey, 07079

  • Mercy Research

    Springfield, Missouri, 65806

  • Washington University

    St Louis, Missouri, 63110

  • Tekwani Vision Center

    St Louis, Missouri, 63128

  • Ophthalmology Associates

    St Louis, Missouri, 63131

  • Opthalmology Consultants Ltd.

    St Louis, Missouri, 63131

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Score Physician Alliance, LLC

    St. Petersburg, Florida, 33710

  • East Florida Eye Institute

    Stuart, Florida, 34494

  • Lone Star Eye Care, P.A.

    Sugar Land, Texas, 77479

  • Walman Eye Center

    Sun City, Arizona, 85351

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

    Tamarac, Florida, 33321

  • Logan Ophthalmic Research, LLC

    Tamarac, Florida, 33321

  • International Research Center

    Tampa, Florida, 33603

  • East West Eye Institute

    Torrance, California, 90505

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505

  • South Shore Eye Care

    Wantagh, New York, 11793

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291

  • SkyVision Centers

    Westlake, Ohio, 44145

  • Windham Eye Group

    Willimantic, Connecticut, 06226

  • Clinical Eye Research of Boston

    Winchester, Massachusetts, 02114

  • James Branch, M.D.

    Winston-Salem, North Carolina, 27101

  • Wyomissing Optometric Center

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Israel7 sites

  • HaEmek Medical Center

    Afula, 18341

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam MC

    Haifa, 3109601

  • Sharey Zedek MC

    Jerusalem, 9103102

  • Rabin Medical Center-Beilinson Campus.

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Medical Center

    Tel Aviv, 64239

Other trials in Israel

Hungary5 sites

  • Debreceni Egyetem

    Debrecen, 4032

  • Bugat Pal Hospital Clinexpert Gyongyos

    Gyöngyös, Heves County, 3200

  • Kaposi Mór Hospital

    Kaposvár, 7400

  • SZTE Szemeszeti Klinika

    Szeged, Csongrád megye, 6720

  • Csolnoky Ferenc Korhaz

    Veszprém, 8200

Other trials in Hungary

Poland5 sites

  • Szpital Specjalistyczny nr 1

    Bytom, 41-902

  • Centrum Medyczne Uno-Med

    Krakow, Malopolska, 31-070

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424

  • Centrum Medyczne Uno-Med

    Tarnów, 33-100

  • Retina Sp. z o.o.

    Warsaw, 01 -364

Other trials in Poland

Spain4 sites

  • Clinica Oftalmologia Gil Piña

    Huelva, 21002

  • Clinica Rementeria

    Madrid, 28010

  • Instituto Oftalmológico Fernández-Vega

    Oviedo, Principality of Asturias, 33012

  • Cartujavision

    Seville, 41092

Other trials in Spain

Austria3 sites

  • Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH

    Linz, 4020

  • AKH - Medizinische Universitaet Wien

    Vienna, 1090

  • Vienna Institute for Research in Ocular Surgery

    Vienna, 1140

Other trials in Austria

Estonia3 sites

  • Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)

    Tallinn, 10120

  • East Tallinn Central Hospital Eye Clinic

    Tallinn, 10138

  • Tartu University Hospital

    Tartu, 51010

Other trials in Estonia

Puerto Rico3 sites

  • Emanuelli Research & Development Center, LLC

    Arecibo, 00613

  • Centro Dotal de Investigaciones de Servicios de Salud

    Carolina, 00984

  • Berrocal and Associates

    San Juan, 00907

Other trials in Puerto Rico

South Africa3 sites

  • Newtown Clinical Research Centre

    Johannesburg, Gauteng, 2001

  • Pretoria Eye Institute

    Pretoria, Gauteng, 0082

  • Into Research

    Pretoria, Gauteng, 0181

Other trials in South Africa

Canada2 sites

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

    Ottawa, Ontario, K1H 8L6

  • University of Waterloo School of Optometry and Vision Science

    Waterloo, Ontario, N2L 3G1

Other trials in Canada

Australia1 site

  • University of the Sunshine Coast Clinical Trials Centre

    Sippy Downs, Queensland, 4556

Other trials in Australia

France1 site

  • CHU Limoges - Hopital Dupuytren

    Limoges, Haute Vienne, 87042

Other trials in France

Italy1 site

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

    Bologna, 40138

Other trials in Italy

About this study

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

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.

Being tested
SHP640, PVP-I 0.6%, Placebo
Medical subject headings
Conjunctivitis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHP640Drug

    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%Drug

    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.

  • PlaceboDrug

    Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

Study groups in NCT03004924
Study groupRoleWhat they receive
SHP640ExperimentalParticipants 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.
Receives: Drug: SHP640
PVP-I 0.6%Active comparatorParticipants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
Receives: Drug: PVP-I 0.6%
PlaceboPlacebo comparatorParticipants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5

    Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

    Measured: Day 5

Secondary outcomes (14)

  1. Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5

    Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

    Measured: Baseline, Day 5

  2. Number of Participants With Clinical Resolution

    Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

    Measured: Day 3, 8 and 12

  3. Number of Participants With Bacterial Eradication

    Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.

    Measured: Day 3, 8 and 12

  4. Bulbar Conjunctival Injection Score

    Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.

    Measured: Day 3, 5, 8 and 12

  5. Change From Baseline in the Bulbar Conjunctival Injection Score

    Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.

    Measured: Baseline, Day 3, 5, 8 and 12

  6. Ocular Conjunctival Discharge Score

    Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

    Measured: Day 3, 5, 8 and 12

  7. Change From Baseline in the Ocular Conjunctival Discharge Score

    Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

    Measured: Baseline, Day 3, 5, 8 and 12

  8. Global Clinical Score

    Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

    Measured: Day 3, 5, 8 and 12

  9. Change From Baseline in the Global Clinical Score

    Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.

    Measured: Baseline, Day 3, 5, 8 and 12

  10. Number of Participants With Modified Clinical Resolution

    Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

    Measured: Day 3, 5, 8 and 12

  11. Number of Participants With Expanded Clinical Resolution

    Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.

    Measured: Day 3, 5, 8 and 12

  12. Time to Clinical Resolution

    Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.

    Measured: Baseline to Day 12

  13. Number of Participants Who Used Rescue Medication

    Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.

    Measured: Baseline to Day 12

  14. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.

    Measured: From start of study drug administration up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2016 (estimated)
  2. Study start29 Mar 2017
  3. Primary completion1 Oct 2018
  4. Study completion1 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
753 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03004924
Sponsor's protocol ID
SHP640-303
Other IDs
2016-003361-25, 2016
Status last verified
May 2021
First submitted
19 Dec 2016
Last updated
9 Jun 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHP640 and PVP-I 0.6% in people with Bacterial Conjunctivitis, run by Shire at 163 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in United States, Israel, Hungary, Poland, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 (time frame: Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03004924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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