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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:9/26/2018
Start Date:March 28, 2017
End Date:June 1, 2020
Contact:Shire Contact
Email:ClinicalTransparency@Shire.com
Phone:+1 866 842 5335

Use our guide to learn which trials are right for you!

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 PVP-Iodine and Placebo in the Treatment of Adenoviral 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 adenoviral
conjunctivitis.


Inclusion Criteria:

1. Subjects of any age at Visit 1.

2. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.

3. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye
(the same eye as the AdenoPlus positive eye) confirmed by the presence of the
following minimal clinical signs and symptoms in that same eye.

4. Be willing to discontinue contact lens wear for the duration of the study.

5. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logarithm of the Minimum Angle of
Resolution (logMAR) or better in each eye as measured using an Early Treatment
Diabetic Retinopathy Study (ETDRS) chart.

6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

1. Have known or suspected intolerance or hypersensitivity to the investigational
product, closely related compounds, or any of the stated ingredients.

2. Prior enrollment in a FST100 or SHP640 clinical study.

3. Subjects who are employees, or immediate family members of employees (who are directly
related to study conduct), at the investigational site.

4. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or
planned for the period of the study.

5. Have a preplanned overnight hospitalization during the period of the study.

6. Have active or history of ocular herpes.

7. 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-adenoviral ocular infection (eg,
bacterial, fungal, acanthamoebal, or other parasitic).

8. Other protocol defined exclusion criteria may apply
We found this trial at
89
sites
9 Ochre Way
Sippy Downs, Queensland 4556
Principal Investigator: Leo Hartley
Phone: (07) 5456 5515
?
mi
from
Sippy Downs,
Click here to add this to my saved trials
900 Northwest 17th Street
Miami, Florida 33136
Principal Investigator: Victoria Chang
Phone: 239-659-3962
?
mi
from
Miami, FL
Click here to add this to my saved trials
Azusa, California 91702
Principal Investigator: Milton Hom
Phone: 626-963-7100
?
mi
from
Azusa, CA
Click here to add this to my saved trials
955 Broadway
Bangor, Maine 04401
Principal Investigator: David T Douglas
Phone: 207-990-4388
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Berlin, New Jersey
Principal Investigator: Michael Hassman
Phone: 856-753-7335
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Bloomington, Minnesota 55431
Principal Investigator: Ahmad Fahmy
Phone: 952-567-6131
?
mi
from
Bloomington, MN
Click here to add this to my saved trials
243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Principal Investigator: Joseph Ciolino
Phone: 617-573-4437
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida 34209
Principal Investigator: Scott Han
Phone: 941-792-2020
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Chandler, Arizona
Principal Investigator: Michael Depenbusch
Phone: 480-999-5458
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29414
Principal Investigator: Ettahleah Bluestein
Phone: 843-769-6655
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chesterfield, Missouri 63017
Principal Investigator: Mujtaba Qazi
Phone: 636-534-5126
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45247
Principal Investigator: Mark Bergmann
Phone: 513-661-3566
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clinton, Utah 84015
Principal Investigator: Samantha Bostrom
Phone: 801-614-5512
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Columbus, Ohio 43215
Principal Investigator: Alice Epitropoulos
Phone: 614-221-7464
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Doylestown, Pennsylvania 18902
Principal Investigator: Cynthia Matossian
Phone: 215-230-9200
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
Edgewood, Kentucky 41017
Principal Investigator: Edward Holland
Phone: 859-331-9000
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
1125 Darlene Lane
Eugene, Oregon 97401
Principal Investigator: Bala Ambati
Phone: 541-762-2763
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Evansville, Indiana 47714
Principal Investigator: Alexander Dela LLana
Phone: 812-471-4110
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fall River, Massachusetts 02721
Principal Investigator: Ehab Sorial
Phone: 508-672-7450
?
mi
from
Fall River, MA
Click here to add this to my saved trials
2516 Sheridan Road Southeast
Falls Church, Virginia 22046
Principal Investigator: Gustavos Corrales
Phone: 202-239-0777
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33309
Principal Investigator: Sunir Joshi
Phone: 714-390-6980
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
5865 West Utopia Road
Glendale, Arizona 85308
Principal Investigator: Kevin Helmuth
Phone: 602-818-4667
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Glendora, California 91741
Principal Investigator: Vicky Pai
Phone: 626-335-0535
?
mi
from
Glendora, CA
Click here to add this to my saved trials
Gretna, Louisiana 70056
Principal Investigator: Monica Monica
Phone: 504-391-7560
?
mi
from
Gretna, LA
Click here to add this to my saved trials
Hemet, California 92545
Principal Investigator: Robert Sorenson
Phone: 951-492-4205
?
mi
from
Hemet, CA
Click here to add this to my saved trials
Henderson, Nevada 89074
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Houston, Texas 77025
Principal Investigator: Kevin Jong
Phone: 713-426-1339
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77034
Principal Investigator: William Lipsky
Phone: 281-338-0425
?
mi
from
Houston, TX
Click here to add this to my saved trials
Irvine, California 92604
Principal Investigator: Eran Duzman
Phone: 949-733-2002
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Kansas City, Missouri 64154
Principal Investigator: Anthony Verachtert
Phone: 816-420-3970
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lake Villa, Illinois 50046
Principal Investigator: Mitchell Jackson
Phone: 847-356-0700
?
mi
from
Lake Villa, IL
Click here to add this to my saved trials
401 Ranch Road 620 South
Lakeway, Texas 78734
Principal Investigator: Kyle Rhodes
Phone: 415-420-4650
?
mi
from
Lakeway, TX
Click here to add this to my saved trials
Las Vegas, Nevada
Principal Investigator: Emil Stein
Phone: 973-937-8839
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
League City, Texas 77573
Principal Investigator: Da-Thuy Van
Phone: 281-332-3937
?
mi
from
League City, TX
Click here to add this to my saved trials
Lexington, Kentucky 40509
Principal Investigator: Bruce Koffler
Phone: 859-263-4631
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lexington, Kentucky 40517
Principal Investigator: Paul Karpecki
Phone: 8592789393131
?
mi
from
Lexington, KY
Click here to add this to my saved trials
300 Shire Way
Lexington, Massachusetts 02421
Principal Investigator: Shire Physician
Phone: 866-842-5335
?
mi
from
Lexington, MA
Click here to add this to my saved trials
3325 Palo Verde Avenue
Long Beach, California 90808
Principal Investigator: Wayne L Freeman
Phone: 562-421-2757
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California
Principal Investigator: Jonathan Macy
Phone: 310-657-2777
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90020
Principal Investigator: Sok Nam
Phone: 213-368-0338
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
4101 Taylorsville Road
Louisville, Kentucky 40220
Principal Investigator: Mohammad Haider
Phone: 502-883-1015
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Sarah Nehls
Phone: 608-263-7169
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Mason, Ohio 45040
?
mi
from
Mason, OH
Click here to add this to my saved trials
825 Ridge Lake Boulevard
Memphis, Tennessee 38120
Principal Investigator: Henry McQuirter
Phone: 901-685-2200
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Memphis, Tennessee
Principal Investigator: Eugene McLaurin
Phone: 901-761-4620
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Meriden, Connecticut 06824
?
mi
from
Meriden, CT
Click here to add this to my saved trials
1800 Northwest 10th Avenue
Miami, Florida 33125
Principal Investigator: Jorge Alvarez-Moreno
Phone: 305-649-7999
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33166
Principal Investigator: Leonardo Allende
Phone: 786-521-8103
?
mi
from
Miami, FL
Click here to add this to my saved trials
1506 East Griffin Parkway
Mission, Texas 78572
Principal Investigator: Pankajkumar Shah
Phone: 956-205-0492
?
mi
from
Mission, TX
Click here to add this to my saved trials
Morrow, Georgia 30260
Principal Investigator: Harvey DuBiner
Phone: 770-968-8888
?
mi
from
Morrow, GA
Click here to add this to my saved trials
Nashville, Tennessee 37205
Principal Investigator: Gary Jerkins
Phone: 615-915-5061
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: Melissa Toyos
Phone: 615-327-4015
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10022
Principal Investigator: Kevin Rosin
Phone: 212-355-5145
?
mi
from
New York, NY
Click here to add this to my saved trials
Orlando, Florida 32825
Principal Investigator: Maricor Grio
Phone: 407-271-4208
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Paducah, Kentucky 42001
Principal Investigator: Carl W Baker
Phone: 270-443-4393
?
mi
from
Paducah, KY
Click here to add this to my saved trials
2452 Watson Court
Palo Alto, California 94303
Principal Investigator: Charles Lin
Phone: 650-497-7935
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Peoria, Illinois 61615
Principal Investigator: Steve J Lichtenstein
Phone: 309-213-0664
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Petaluma, California 94954
Principal Investigator: Jason Bacharach
Phone: 707-769-2240
?
mi
from
Petaluma, CA
Click here to add this to my saved trials
Phoenix, Arizona
Principal Investigator: Jung Dao
Phone: 602-258-4342
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburg, Kansas 66762
Principal Investigator: Shane Kannarr
Phone: 620-235-1737
?
mi
from
Pittsburg, KS
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Principal Investigator: Deepinder Dhaliwal
Phone: 412-383-9884
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Poway, California 92064
Principal Investigator: Jeffrey Lozier
Phone: 858-613-2965
?
mi
from
Poway, CA
Click here to add this to my saved trials
3192 Willow Creek Road
Prescott, Arizona 86301
Principal Investigator: Steven Mortenson
Phone: 480-999-5458
?
mi
from
Prescott, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27603
Principal Investigator: Carol Aune
Phone: 252-904-5415
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rancho Cordova, California 95670
Principal Investigator: Joseph Martel
Phone: 916-631-7860
?
mi
from
Rancho Cordova, CA
Click here to add this to my saved trials
Rapid City, South Dakota 57701
Principal Investigator: Terrence Spencer
Phone: 605-719-3153
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Redding, California
Principal Investigator: Bruce Silverstein
Phone: 530-223-2500
?
mi
from
Redding, CA
Click here to add this to my saved trials
Roseville, California 95661
Principal Investigator: Jeffrey Wayne
Phone: 916-434-8230
?
mi
from
Roseville, CA
Click here to add this to my saved trials
Sacramento, California 95815
Principal Investigator: Samuel Lee
Phone: 916-649-1515
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63131
Principal Investigator: Gregg Berdy
Phone: 314-966-3377
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63131
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33710
Principal Investigator: Jeffrey Hirschfield
Phone: 985-257-2673
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Antonio, Texas 78229
Principal Investigator: Robert Rice
Phone: 210-424-2584
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92604
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
Principal Investigator: Michael Sheety
Phone: 714-647-1200
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
8416 E. Shea Blvd., Ste C-101
Scottsdale, Arizona 85260
Principal Investigator: Marc Bloomstein
Phone: 480-483-3937
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
South Orange, New Jersey 07079
Principal Investigator: Charles Crane
Phone: 973-763-2203
?
mi
from
South Orange, NJ
Click here to add this to my saved trials
Springfield, Missouri 65806
Principal Investigator: Shachar Tauber
Phone: 417-820-7493
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Stuart, Florida 34994
Principal Investigator: Ronald Frenkel
Phone: 772-223-5990
?
mi
from
Stuart, FL
Click here to add this to my saved trials
3515 Town Center Boulevard
Sugar Land, Texas 77479
Principal Investigator: Matthew McMenemy
Phone: 832-606-7778
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
10615 West Thunderbird Boulevard
Sun City, Arizona 85351
Principal Investigator: Gerald Walman
Phone: 480-999-5458
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
Tamarac, Florida 33321
Principal Investigator: Andrew Logan
Phone: 954-724-5100
?
mi
from
Tamarac, FL
Click here to add this to my saved trials
West Monroe, Louisiana 71291
Principal Investigator: Jonathan Scogin
Phone: 318-325-2610
?
mi
from
West Monroe, LA
Click here to add this to my saved trials
Westlake, Ohio 44145
?
mi
from
Westlake, OH
Click here to add this to my saved trials
83 Quarry Street
Willimantic, Connecticut 06226
Principal Investigator: Michael Cooper, OD
Phone: 860-423-1619
?
mi
from
Willimantic, CT
Click here to add this to my saved trials
Winchester, Massachusetts 01890
Principal Investigator: Jack Greiner
Phone: 781-729-3008
?
mi
from
Winchester, MA
Click here to add this to my saved trials
Winston-Salem, North Carolina
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
50 Berkshire Court
Wyomissing, Pennsylvania 19610
Principal Investigator: Glenn Corbin
Phone: 610-374-3134
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials