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

PHASE3TerminatedINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

March 27, 2017

Primary Completion Date

May 13, 2019

Study Completion Date

May 13, 2019

Conditions
Adenoviral Conjunctivitis
Interventions
DRUG

SHP640

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.

DRUG

PVP-I 0.6%

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.

OTHER

Placebo

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

Trial Locations (130)

27

Macula D&T S.R.L., Lima

Oftalmosalud SRL., Lima

83

Pretoria Eye Institute Research Foundation, Pretoria

1090

AKH - Medizinische Universitaet Wien, Vienna

1140

Vienna Institute for Research in Ocular Surgery, Vienna

2113

Newtown Clinical Research, Johannesburg

3200

Bugat Pal Korhaz, Gyöngyös

4001

Nelson R Mandela School of Medicine Ophthalmology Department, Durban

4020

Kepler Universitätsklinikum, Linz

4032

Debreceni Egyetem, Debrecen

4556

University of the Sunshine Coast Clinical Trials Centre, Sippy Downs

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

8200

Csolnoky Ferenc Korhaz, Veszprém

9006

Complejo Asistencial Universitario de Burgos, Burgos

10120

Eye Clinic Dr Kirsta Turman, Tallinn

10138

East Tallinn Central Hospital, Tallinn

13007

Instituto Regional de Oftalmología, La Libertad

15213

UPMC Eye Center, Pittsburgh

17001

Hospital Universitari de Girona Dr Josep Trueta, Girona

18341

HaEmek Medical Center, Afula

18902

Matossian Eye Associates, Doylestown

19610

Wyomissing Optometric Center, Wyomissing

21002

Clinica Oftalmologia Gil Piña, Huelva

22046

Emerson Clinical Research Institute, LLC, Falls Church

27101

James Branch, M.D., Winston-Salem

27603

Oculus Research, Raleigh

28010

Clinica Rementeria, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

30260

Eye Care Centers Management, Inc., Morrow

32825

Pediatric & Adult Research Center, LLC, Orlando

33012

Instituto Oftalmológico Fernández-Vega, Oviedo

33136

Bascom Palmer Eye Institute, Miami

33166

Lorites Medical Group, Miami

33309

South Florida Vision Associates, LLC, Fort Lauderdale

33321

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

34209

The Eye Associates, Bradenton

34494

East Florida Eye Institute, Stuart

37205

Nashville Vision Associates, Nashville

37215

Toyos Clinic, Nashville

38104

The Eye Center at Southern College of Optometry, Memphis

38119

Total Eye Care, PA, Memphis

38120

Eye Specialty Group, Memphis

40138

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

40220

Senior Health Services, Louisville

40509

Koffler Vision Group, Lexington

40517

Kentucky Eye Institute, Lexington

41092

Cartuja Vision, Seville

42001

Baker, Carl W, Paducah

46015

FISABIO-Oftalmología Médica, Valencia

47714

MediSphere Medical Research Center, an AMR affiliate, Evansville

48105

The Regents of the University of Michigan, Ann Arbor

48145

Augenärzte am Franziskus Hospital, Münster

49100

Rabin Medical Center-Beilinson Campus, Petah Tikva

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

Hospital Universitario Miguel Servet, Zaragoza

51010

Tartu University Hospital, Tartu

53705

University of Wisconsin, Madison

55131

Klinisches Studienzentrum der Augenklinik, Mainz

55431

Minnesota Eye Consultants, P.A., Bloomington

59101

Black Hills Regional Eye Institute, Rapid City

60046

Jackson Eye, Lake Villa

61615

Illinois Eye Center, Peoria

63017

Lifelong Vision Foundation, Chesterfield

64154

Moyes Eye Center, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65806

Mercy Research, Springfield

66762

Kannarr Eye Care, Pittsburg

70056

Lakeview Vision - Gretna, Gretna

71291

Haik Humble Eye Center, West Monroe

75015

Hopital Necker - Enfants Malades, Paris

76100

Kaplan Medical Center, Rehovot

77025

Houston Eye Associates, Houston

77479

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

77573

Houston Eye Associates, League City

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

84015

Ericksen Research & Development, LLC, Clinton

84101

Soroka University Medical Center, Beersheba

85224

Arizona Eye Center, Chandler

85308

Midwestern University Eye Institute, Glendale

85351

Walman Eye Center, Sun City

86301

M&M Eye Institute, Prescott

87042

CHU Limoges - Hopital Dupuytren, Limoges

89129

Nevada Eye Care Professionals, Las Vegas

90020

Oxford Optical, Los Angeles

90048

Macy Eye Center, Los Angeles

90808

Eye Physicians of Long Beach, Long Beach

91325

Shultz Chang Vision, Northridge

91702

Milton M. Hom, OD, FAAO, Azusa

91741

Mark B. Kislinger, MD, PhD, Inc., Glendora

92064

Arch Health Partners, Poway

92354

Loma Linda University, Loma Linda

92545

Inland Eye Specialists, Hemet

92604

Lakeside Vision Center, Irvine

94303

Stanford Byers Eye Institute, Palo Alto

94954

North Bay Eye Associates, Inc., Petaluma

95670

Martel Eye Medical Group, Rancho Cordova

96002

Shasta Eye Medical Group, Inc., Redding

201301

ICARE Eye Hospital and Post Graduate Institute, Noida

334003

S. P. Medical College & Associated Group of Hospitals, Bikaner

400706

Dr. D. Y. Patil Medical College, Navi Mumbai

411060

PBMA'S H. V. Desai Eye Hospital, Pune

440025

NKP Salve Institute of Medical Sciences, Nagpur

500034

L. V. Prasad Eye Institute, Hyderabad

560037

Sankara Eye Hospital, Bangalore

560052

Bhagwan Mahaveer Jain Hospital, Bangalore

560054

M. S. Ramaiah Medical College and Hospital, Bangalore

560090

Sapthagiri Hospital, Bangalore

590010

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

700073

Regional Institute of Ophthalmology, Kolkata

3109601

Rambam MC, Haifa

9103102

Shaare Zedek Medical Center, Jerusalem

04401

Eye Center Northeast, Bangor

02114

Massachusetts Eye and Ear Infirmary, Boston

Clinical Eye Research of Boston, Winchester

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

H4A 3S5

McGill University Health Centre/Glen Site / Royal Victoria Hospital, Montreal

41-902

Szpital Specjalistyczny nr 1, Bytom

31-070

Centrum Medyczne UNO-MED, Krakow

10-424

Centrum Diagnostyki i Mikrochirurgii Oka LENS, Olsztyn

33-100

Centrum Medyczne Uno-Med (Private Practice), Tarnów

01 -364

Retina Sp. z o.o., Warsaw

0181

Into Research, Pretoria

M139WL

Manchester Royal Eye Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY