Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
Status: | Completed |
---|---|
Conditions: | Ocular, Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/16/2018 |
Start Date: | March 29, 2017 |
End Date: | October 1, 2018 |
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.
compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial
conjunctivitis.
Inclusion Criteria:
- 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.
- Subjects of any age at Visit 1 (Note: subjects 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:
1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less
than or equal to (<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar
Conjunctival Injection Scale
3. 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 subjects <
2 months of age who have not yet developed this ability. Subjects < 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.
Exclusion Criteria:
- 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 subject 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.
- Subjects 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 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, subjects 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, subjects 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:
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.
We found this trial at
61
sites
955 Broadway
Bangor, Maine 04401
Bangor, Maine 04401
Principal Investigator: David Douglas
Phone: 207-990-4388
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Berlin, New Jersey
Principal Investigator: Michael Hassman
Phone: 856-753-7335
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Bloomingdale, Illinois 60108
Principal Investigator: Lisa Wohl, MD
Phone: 630-351-2030
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Bloomington, Minnesota 55431
Principal Investigator: Ahmad Fahmy
Phone: 952-567-6070
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Bradenton, Florida 34209
Principal Investigator: Scott Han
Phone: 941-792-2020
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Charleston, South Carolina 29414
Principal Investigator: Ettahleah Bluestein
Phone: 843-769-6655
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Chesterfield, Missouri 63017
Principal Investigator: Mujtaba Qazi
Phone: 636-534-5126
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2225 Port Chicago Highway
Concord, California 94520
Concord, California 94520
Principal Investigator: Clark Tsai
Phone: 925-686-2020
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1125 Darlene Lane
Eugene, Oregon 97401
Eugene, Oregon 97401
Principal Investigator: Bala Ambati
Phone: 541-762-2763
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Evansville, Indiana 47714
Principal Investigator: Alexander Dela LLana
Phone: 812-471-4110
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Fairfield, Connecticut 06824
Principal Investigator: James Thimons
Phone: 203-366-8000
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Fall River, Massachusetts 02721
Principal Investigator: Ehab Sorial
Phone: 508-672-7450
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2516 Sheridan Road Southeast
Falls Church, Virginia 22046
Falls Church, Virginia 22046
Principal Investigator: Gustavo Corrales
Phone: 202-239-0777
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2900 West Cypress Creek Road
Fort Lauderdale, Florida 33309
Fort Lauderdale, Florida 33309
Principal Investigator: Sunir Joshi
Phone: 954-977-0192
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210 South Grand Avenue
Glendora, California 91741
Glendora, California 91741
Principal Investigator: Vicky Pai
Phone: 626-335-0535
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120 Ochsner Boulevard
Gretna, Louisiana 70056
Gretna, Louisiana 70056
Principal Investigator: Monica Monica
Phone: 504-391-7560
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Hemet, California 92545
Principal Investigator: Robert Sorenson
Phone: 951-492-4205
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2598 Windmill Parkway
Henderson, Nevada 89074
Henderson, Nevada 89074
Principal Investigator: Lorenz Lorenz
Phone: 702-588-1076
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Houston, Texas 77025
Principal Investigator: Carlos Gonzales, MD
Phone: 832-280-3642
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Irvine, California 92604
Principal Investigator: Eran Duzman
Phone: 949-733-2002
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7205 Bonneval Road
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Principal Investigator: Frank Bowden, MD
Phone: 904-296-0098
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7730 West Cheyenne Avenue
Las Vegas, Nevada 89129
Las Vegas, Nevada 89129
Principal Investigator: Emil Stein
Phone: 973-937-8839
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300 Shire Way
Lexington, Massachusetts 02421
Lexington, Massachusetts 02421
Principal Investigator: Shire physician
Phone: 866-842-5335
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3325 Palo Verde Avenue
Long Beach, California 90808
Long Beach, California 90808
Principal Investigator: Wayne Freeman
Phone: 562-421-2757
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4278 West 3rd Street
Los Angeles, California 90020
Los Angeles, California 90020
Principal Investigator: Sok Nam
Phone: 213-368-0388
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Louisville, Kentucky 40220
Principal Investigator: Mohammad Haider
Phone: 502-883-1015
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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...
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825 Ridge Lake Boulevard
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Principal Investigator: Henry . McQuirter
Phone: 901-685-2200
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1800 Northwest 10th Avenue
Miami, Florida 33125
Miami, Florida 33125
Principal Investigator: orge Alvarez-Moreno
Phone: 305-649-7999
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1506 East Griffin Parkway
Mission, Texas 78572
Mission, Texas 78572
Principal Investigator: Pankajkumar Shah
Phone: 956-205-0492
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Nashville, Tennessee 37205
Principal Investigator: Gary Jerkins
Phone: 615-915-5086
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30 East 60th Street
New York, New York 10022
New York, New York 10022
Principal Investigator: Kevin Rosin
Phone: 212-355-5145
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6500 Porter Road
Niagara Falls, New York 14304
Niagara Falls, New York 14304
Principal Investigator: Thomas Elmer, MD
Phone: 716-828-8970
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Orlando, Florida 32825
Principal Investigator: Maricor Grio
Phone: 407-271-4208
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Peoria, Illinois 61615
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Phone: 309-213-0664
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Phone: 602-258-4342
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Deepinder Dhaliwal
Phone: 412-383-9033
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3192 Willow Creek Road
Prescott, Arizona 86301
Prescott, Arizona 86301
Principal Investigator: Steven Mortenson
Phone: 480-999-5458
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Raleigh, North Carolina 27603
Principal Investigator: Carol Aune
Phone: 713-816-3185
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Redding, California
Principal Investigator: Bruce Silverstein
Phone: 530-223-2500
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Sacramento, California 95815
Principal Investigator: Samuel Lee
Phone: 916-649-1515
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736 South 900 East
Saint George, Utah 84790
Saint George, Utah 84790
Principal Investigator: Jason Hendrix
Phone: 435-656-1704
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8416 E. Shea Blvd., Ste C-101
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
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Phone: 480-483-3937
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9 Ochre Way
Sippy Downs, Queensland 4556
Sippy Downs, Queensland 4556
Principal Investigator: Leo Hartley
Phone: (07) 5353 5080
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South Orange, New Jersey 07079
Principal Investigator: Charles Crane
Phone: 973-763-2203
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Stuart, Florida 34994
Principal Investigator: Ronald Frenkel
Phone: 772-287-9000
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3515 Town Center Boulevard
Sugar Land, Texas 77479
Sugar Land, Texas 77479
Principal Investigator: Matthew McMenemy
Phone: 832-606-7778
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10615 West Thunderbird Boulevard
Sun City, Arizona 85351
Sun City, Arizona 85351
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Phone: 480-999-5458
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Tamarac, Florida 33321
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Phone: 954-724-5100
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Tampa, Florida
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Torrance, California 90505
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1804 North 7th Street
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
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Phone: 318-325-2610
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83 Quarry Street
Willimantic, Connecticut 06226
Willimantic, Connecticut 06226
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Phone: 860-423-1619
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50 Berkshire Court
Wyomissing, Pennsylvania 19610
Wyomissing, Pennsylvania 19610
Principal Investigator: Glenn Corbin
Phone: 610-374-3134
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