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

PHASE3CompletedINTERVENTIONAL
Enrollment

753

Participants

Timeline

Start Date

March 29, 2017

Primary Completion Date

October 1, 2018

Study Completion Date

October 1, 2018

Conditions
Bacterial Conjunctivitis
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (163)

1090

AKH - Medizinische Universitaet Wien, Vienna

1140

Vienna Institute for Research in Ocular Surgery, Vienna

2001

Newtown Clinical Research Centre, Johannesburg

3200

Bugat Pal Hospital Clinexpert Gyongyos, Gyöngyös

4020

Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH, Linz

4032

Debreceni Egyetem, Debrecen

4556

University of the Sunshine Coast Clinical Trials Centre, Sippy Downs

6720

SZTE Szemeszeti Klinika, Szeged

7400

Kaposi Mór Hospital, Kaposvár

8200

Csolnoky Ferenc Korhaz, Veszprém

10022

Farkas, Kassalow, Resnick &Associates, New York

10120

Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus), Tallinn

10138

East Tallinn Central Hospital Eye Clinic, Tallinn

11793

South Shore Eye Care, Wantagh

14304

Fichte, Endl& Elmer Eyecare, Niagara Falls

15213

UPMC Eye Center, Pittsburgh

18341

HaEmek Medical Center, Afula

18902

Matossian Eye Associates, Doylestown

19148

Philadelphia Eye Associates, Philadelphia

19610

Wyomissing Optometric Center, Wyomissing

21002

Clinica Oftalmologia Gil Piña, Huelva

22046

Emerson Clinical Research Institute, Falls Church

24502

Piedmont Eye Center, Inc., Lynchburg

27101

James Branch, M.D., Winston-Salem

27603

Oculus Research at Garner EyeCareCenter, Raleigh

28010

Clinica Rementeria, Madrid

29414

Bluestein Custom Vision, Charleston

30260

Eye Care Centers Management, Inc., Morrow

32256

Bowden Eye & Associates, Jacksonville

32825

Pediatric & Adult Research Center, LLC, Orlando

33012

Instituto Oftalmológico Fernández-Vega, Oviedo

33125

Millenium Clinical Research, Miami

Millennium Clinical Research, Inc., Miami

33135

South Florida Research Center Inc., Miami

33136

Bascom Palmer Eye Institute, Miami

33166

Lorites Medical Group, Miami

33309

South Florida Vision, Fort Lauderdale

33321

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

Logan Ophthalmic Research, LLC, Tamarac

33484

Bruce A. Segal, MD, PA, Delray Beach

33603

International Research Center, Tampa

33710

Score Physician Alliance, LLC, St. Petersburg

33773

Shettle Eye Research, Inc., Largo

33948

Medsol Clinical Research Center, Port Charlotte

34209

The Eye Associates of Manatee, LLP, Bradenton

34494

East Florida Eye Institute, Stuart

37205

Nashville Vision Associates, Nashville

37215

Toyos Clinic, Nashville

38119

Total Eye Care, PA, Memphis

38120

Eye Specialty Group, Memphis

40138

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

40206

The Eye Care Institute, Louisville

40220

Dr. Haider Eye Care, Louisville

Senior Health Services, Louisville

40509

Koffler Vision Group, Lexington

40517

Kentucky Eye Institute, Lexington

41017

Cincinnati Eye Institute, Edgewood

41092

Cartujavision, Seville

42001

Baker, Carl W, Paducah

43210

The Ohio State University, Columbus

43215

The Columbus Eye Center, Columbus

44141

Cleveland Eye Clinic, Cleveland

44145

SkyVision Centers, Westlake

45236

Apex Eye Kenwood, Cincinnati

45242

Cincinnati Eye Institute, Cincinnati

45247

Apex Eye, Cincinnati

46290

Midwest Cornea Associates, LLC, Indianapolis

47714

MediSphere Medical Research Center, LLC, Evansville

49100

Rabin Medical Center-Beilinson Campus., Petah Tikva

51010

Tartu University Hospital, Tartu

53705

University of Wisconsin, Madison

55431

Minnesota Eye Consultants, P.A, Bloomington

59101

Black Hills Regional Eye Institute, Rapid City

60046

Jackson Eye, Lake Villa

60108

Wohl Eye Center, Bloomingdale

61615

Illinois Eye Center, Peoria

63017

Lifelong Vision Foundation, Chesterfield

63110

Washington University, St Louis

63128

Tekwani Vision Center, St Louis

63131

Ophthalmology Associates, St Louis

Opthalmology Consultants Ltd., St Louis

64133

Silverstein Eye Centers, Kansas City

64154

Moyes Eye Center, Kansas City

64239

Tel Aviv Medical Center, Tel Aviv

65806

Mercy Research, Springfield

66211

Sabates Eye Centers, Leawood

66762

Kannarr Eye Care, Pittsburg

70056

Lakeview Vision, Gretna

71291

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center, West Monroe

73120

IPS Research Company*, Oklahoma City

76100

Kaplan Medical Center, Rehovot

77025

Houston Eye Associates, Houston

77034

Advanced Laser Vision & Surgical Institute, Houston

77479

Lone Star Eye Care, P.A., Sugar Land

78215

Sun Research Institute, LLC, San Antonio

78229

R and R Eye Research, LLC., San Antonio

78572

DCT- Shah Research, LLC dba Discovery Clinical Trials, Mission

78734

Lake Travis Eye & Laser Center, Lakeway

79934

Eyeland Vision, El Paso

80134

Specialty Eye Care, Parker

83686

Saltzer Medical Group, Nampa

84015

Ericksen Research & Development, LLC, Clinton

84101

Soroka University Medical Center, Beersheba

84107

The Eye Institute of Utah, Salt Lake City

84117

Jean Brown Research, Salt Lake City

84790

Chrysalis Clinical Research, St. George

85032

Cornea and Cataract Consultants of Arizona, Phoenix

85225

Arizona Eye Center, Chandler

85260

Schwartz Laser Eye Center, Scottsdale

85351

Walman Eye Center, Sun City

86301

M&M Eye Institute, Prescott

87042

CHU Limoges - Hopital Dupuytren, Limoges

89074

NV Eye Physicians, Henderson

89119

Wellish Vision Institute, Las Vegas

89129

Emil A. Stein, M.D., Ltd., Las Vegas

90020

Oxford Optical, Los Angeles

Sok H. Nam, M.D. Inc., Los Angeles

90033

University of Southern California, Los Angeles

90048

Macy Eye Center, Los Angeles

90505

East West Eye Institute, Torrance

Wolstan & Goldberg Eye Associates, Torrance

90808

Eye Physicians of Long Beach, Long Beach

91204

Lugene Eye Institute Inc, Glendale

91345

North Valley Eye Medical Group Inc, Mission Hills

91702

Milton M. Hom, OD, FAAO, Azusa

91741

Mark B. Kislinger, MD, Inc., Glendora

92064

Arch Health Partners, Poway

92545

Inland Eye Specialists, Hemet

92604

Lakeside Vision Center, Irvine

92705

WCCT Global (PH 1 Unit), Santa Ana

93534

Hull Eye Center, Lancaster

94520

Clark S Tsai Eye Center, Concord

94954

North Bay Eye Associates, Inc., Petaluma

95661

Clinical Trials Research, Roseville

95670

Martel Eye Medical Group, Rancho Cordova

95815

Sacramento Eye Consultants, Sacramento

96001

Shasta Eye Medical Group, Inc., Redding

96814

Jenkins Eye Care, Honolulu

97401

Pacific Clear Vision Institute, Eugene

3109601

Rambam MC, Haifa

9103102

Sharey Zedek MC, Jerusalem

06810

Danbury Eye Physicians and Surgeons, Danbury

06824

Ophthalmic Consultants of Connecticut, Meriden

06226

Windham Eye Group, Willimantic

04401

Eye Center Northeast, Bangor

02114

Massachusetts Eye and Ear Infirmary, Boston

Clinical Eye Research of Boston, Winchester

02721

NECCR PrimaCare Research, Fall River

02421

Shire Call Center, Lexington

08009

Hassman Research Institute, Berlin

07079

Northern New Jersey Eye Institute, South Orange

K1H 8L6

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

N2L 3G1

University of Waterloo School of Optometry and Vision Science, Waterloo

31-070

Centrum Medyczne Uno-Med, Krakow

41-902

Szpital Specjalistyczny nr 1, Bytom

10-424

Centrum Diagnostyki i Mikrochirurgii Oka LENS, Olsztyn

33-100

Centrum Medyczne Uno-Med, Tarnów

01 -364

Retina Sp. z o.o., Warsaw

00613

Emanuelli Research & Development Center, LLC, Arecibo

00984

Centro Dotal de Investigaciones de Servicios de Salud, Carolina

00907

Berrocal and Associates, San Juan

0082

Pretoria Eye Institute, Pretoria

0181

Into Research, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY