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

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ClinicalTrials.gov Identifier: NCT03004924
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: SHP640 Drug: PVP-I 0.6% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 753 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: SHP640
Instill 1 drop of SHP640 (0.6 percent (%) povidone-iodine [PVP-I] and 0.1% Dexamethasone and) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Drug: SHP640
Instill 1 drop of SHP640 (0.6% povidone-iodine [PVPI] and 0.1% Dexamethasone ) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.

Active Comparator: PVP-I 0.6%
Instill 1 drop of 0.6% PVP-I ophthalmic solution in each eye 4 times QID for 7 days
Drug: PVP-I 0.6%
Instill 1 drop of 0.6% PVP-I ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

Placebo Comparator: Placebo
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID 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.




Primary Outcome Measures :
  1. Clinical Resolution status between SHP640 and placebo as Measured by absence of Bulbar Conjunctival Injection and ocular conjunctival discharge [ Time Frame: Day 5 ]
    Clinical resolution of bacterial conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and ocular conjunctival discharge scores at baseline as well as his/her bacterial culture results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.


Secondary Outcome Measures :
  1. Bacterial Eradication Status between SHP640 and Placebo as Measured by Absence of All Bacterial Species Present at or Above Pathological Threshold at Baseline [ Time Frame: Day 5 ]
    Bacterial eradication status of the study eye is defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye at Day 5. The study eye is defined based on subject's bulbar conjunctival redness and ocular conjunctival discharge scores at baseline as well as his/her bacterial culture results at baseline.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004924


  Show 89 Study Locations
Sponsors and Collaborators
Shire
Investigators
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Study Director: Shire Physician Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03004924     History of Changes
Other Study ID Numbers: SHP640-303
2016-003361-25 ( EudraCT Number )
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eye Diseases
Eye Infections, Bacterial
Eye Infections
Ophthalmic Solutions
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Bacterial Infections
Infection
Pharmaceutical Solutions
Dexamethasone
Dexamethasone acetate
BB 1101
Iodine
Povidone-Iodine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local