Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
NCT ID: NCT02998541
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
219 participants
INTERVENTIONAL
2017-03-27
2019-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHP640
Participants will receive one drop of SHP640 (0.1 percent \[%\] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
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.
PVP-I 0.6%
Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
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.
Placebo
Participants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 lesser than (\<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (\>=) 37 weeks gestational age at birth).
* Meet at least 1 of the 2 criteria below:
a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc).
ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.
iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.
* Have a clinical diagnosis of suspected adenoviral 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 adenoviral conjunctivitis for lesser than or equal to (\<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of \>= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
3. Watery conjunctival discharge: a grade of \>= 1 (mild) on a 0-3 Watery 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 the 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 relevant history of physical or psychiatric illness, any medical disorder that may make the participants 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 pre-planned overnight hospitalization during the period of the study.
* Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
* Have presence of corneal subepithelial infiltrates at Visit 1.
* Have active or 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-adenoviral ocular infection (e.g. bacterial, 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 (i.e. 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 (i.e. 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 (e.g. 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 which requires invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
* Have used any topical ocular or systemic anti-vials or antibiotics within \<= 7 days of enrollment.
* Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) 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 peri-ocular 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 the 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 (antihepatitis 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
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Arizona Eye Center
Chandler, Arizona, United States
Midwestern University Eye Institute
Glendale, Arizona, United States
M&M Eye Institute
Prescott, Arizona, United States
Walman Eye Center
Sun City, Arizona, United States
Milton M. Hom, OD, FAAO
Azusa, California, United States
Mark B. Kislinger, MD, PhD, Inc.
Glendora, California, United States
Inland Eye Specialists
Hemet, California, United States
Lakeside Vision Center
Irvine, California, United States
Loma Linda University
Loma Linda, California, United States
Eye Physicians of Long Beach
Long Beach, California, United States
Oxford Optical
Los Angeles, California, United States
Macy Eye Center
Los Angeles, California, United States
Shultz Chang Vision
Northridge, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Arch Health Partners
Poway, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc.
Redding, California, United States
The Eye Associates
Bradenton, Florida, United States
South Florida Vision Associates, LLC
Fort Lauderdale, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Lorites Medical Group
Miami, Florida, United States
Pediatric & Adult Research Center, LLC
Orlando, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
Tamarac, Florida, United States
Eye Care Centers Management, Inc.
Morrow, Georgia, United States
Jackson Eye
Lake Villa, Illinois, United States
Illinois Eye Center
Peoria, Illinois, United States
MediSphere Medical Research Center, an AMR affiliate
Evansville, Indiana, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Koffler Vision Group
Lexington, Kentucky, United States
Kentucky Eye Institute
Lexington, Kentucky, United States
Senior Health Services
Louisville, Kentucky, United States
Baker, Carl W
Paducah, Kentucky, United States
Lakeview Vision - Gretna
Gretna, Louisiana, United States
Haik Humble Eye Center
West Monroe, Louisiana, United States
Eye Center Northeast
Bangor, Maine, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Shire Call Center
Lexington, Massachusetts, United States
Clinical Eye Research of Boston
Winchester, Massachusetts, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Moyes Eye Center
Kansas City, Missouri, United States
Mercy Research
Springfield, Missouri, United States
Nevada Eye Care Professionals
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Northern New Jersey Eye Institute
South Orange, New Jersey, United States
Oculus Research
Raleigh, North Carolina, United States
James Branch, M.D.
Winston-Salem, North Carolina, United States
Matossian Eye Associates
Doylestown, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Wyomissing Optometric Center
Wyomissing, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
The Eye Center at Southern College of Optometry
Memphis, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Eye Specialty Group
Memphis, Tennessee, United States
Nashville Vision Associates
Nashville, Tennessee, United States
Toyos Clinic
Nashville, Tennessee, United States
Houston Eye Associates
Houston, Texas, United States
Lake Travis Eye & Laser Center
Lakeway, Texas, United States
Houston Eye Associates
League City, Texas, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
Mission, Texas, United States
R and R Eye Research, LLC.
San Antonio, Texas, United States
Lone Star Eye Care, P.A.
Sugar Land, Texas, United States
Ericksen Research & Development, LLC
Clinton, Utah, United States
Emerson Clinical Research Institute, LLC
Falls Church, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of the Sunshine Coast Clinical Trials Centre
Sippy Downs, Queensland, Australia
Kepler Universitätsklinikum
Linz, , Austria
AKH - Medizinische Universitaet Wien
Vienna, , Austria
Vienna Institute for Research in Ocular Surgery
Vienna, , Austria
The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
Ottawa, Ontario, Canada
University of Waterloo School of Optometry and Vision Science
Waterloo, Ontario, Canada
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal, Quebec, Canada
Eye Clinic Dr Kirsta Turman
Tallinn, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
CHU Limoges - Hopital Dupuytren
Limoges, Haute Vienne, France
Hopital Necker - Enfants Malades
Paris, , France
Klinisches Studienzentrum der Augenklinik
Mainz, , Germany
Augenärzte am Franziskus Hospital
Münster, , Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, Hungary
Bugat Pal Korhaz
Gyöngyös, Heves County, Hungary
Debreceni Egyetem
Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Csolnoky Ferenc Korhaz
Veszprém, , Hungary
L. V. Prasad Eye Institute
Hyderabad, Andhra Pradesh, India
Sankara Eye Hospital
Bangalore, Karnataka, India
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, India
M. S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India
Sapthagiri Hospital
Bangalore, Karnataka, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
NKP Salve Institute of Medical Sciences
Nagpur, Maharashtra, India
Dr. D. Y. Patil Medical College
Navi Mumbai, Maharashtra, India
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, India
S. P. Medical College & Associated Group of Hospitals
Bikaner, Rajasthan, India
ICARE Eye Hospital and Post Graduate Institute
Noida, Uttar Pradesh, India
Regional Institute of Ophthalmology
Kolkata, West Bengal, India
HaEmek Medical Center
Afula, , Israel
Soroka University Medical Center
Beersheba, , Israel
Rambam MC
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
A.O.U. Policlinico San'Orsola-Malpighi
Bologna, , Italy
Instituto Regional de Oftalmología
La Libertad, , Peru
Macula D&T S.R.L.
Lima, , Peru
Oftalmosalud SRL.
Lima, , Peru
Szpital Specjalistyczny nr 1
Bytom, , Poland
Centrum Medyczne UNO-MED
Krakow, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, , Poland
Centrum Medyczne Uno-Med (Private Practice)
Tarnów, , Poland
Retina Sp. z o.o.
Warsaw, , Poland
Newtown Clinical Research
Johannesburg, Gauteng, South Africa
Into Research
Pretoria, Gauteng, South Africa
Pretoria Eye Institute Research Foundation
Pretoria, Gauteng, South Africa
Nelson R Mandela School of Medicine Ophthalmology Department
Durban, KwaZulu-Natal, South Africa
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias, Spain
Complejo Asistencial Universitario de Burgos
Burgos, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Clinica Oftalmologia Gil Piña
Huelva, , Spain
Clinica Rementeria
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Cartuja Vision
Seville, , Spain
FISABIO-Oftalmología Médica
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Manchester Royal Eye Hospital
Manchester, Greater Manchester, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002439-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP640-301
Identifier Type: -
Identifier Source: org_study_id
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