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Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo

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ClinicalTrials.gov Identifier: NCT02998554
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

December 16, 2016
December 20, 2016
September 25, 2018
April 11, 2017
November 1, 2019   (Final data collection date for primary outcome measure)
Proportion of Participants With Clinical Resolution on Day 6 [ Time Frame: Day 6 ]
Clinical resolution of adenoviral conjunctivitis is defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 bulbar conjunctival injection scale which uses pictures from the validated bulbar redness (VBR) scale and watery conjunctival discharge will be assessed based on a 0-3 watery conjunctival discharge scale. Higher scores represent worse symptoms for both scales.
Clinical Resolution Status of SHP640 and Placebo as measured by bulbar conjunctival injection and watery conjunctival discharge [ Time Frame: Day 6 ]
Complete list of historical versions of study NCT02998554 on ClinicalTrials.gov Archive Site
  • Proportion of Participants With Adenoviral Eradication on Day 6 [ Time Frame: Day 6 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. The CC-IFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Absolute Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) [ Time Frame: Day 6 and Day 8 ]
    Absolute adenovirus viral titer as assessed by qPCR will be reported.
  • Change From Baseline in the Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) [ Time Frame: Baseline, Day 6 and 8 ]
    The change from baseline in the adenovirus viral titer as assessed by qPCR will be reported.
  • Proportion of Participants With Adenoviral Eradication as Assessed by Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 3, Day 8 and Day 12 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. The CC-IFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at base line as well as his/her CC-IFA results at baseline.
  • Proportion of Participants With Clinical Resolution [ Time Frame: Day 3, Day 8 and Day 12 ]
    Clinical resolution of adenoviral conjunctivitis is defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection will be assessed based on a 0-4 bulbar conjunctival injection scale which uses pictures from the validated bulbar redness (VBR) scale and watery conjunctival discharge will be assessed based on a 0-3 watery conjunctival discharge scale.
  • Clinical Signs Score of Bulbar Conjunctival Injection [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Individual clinical signs score for bulbar conjunctival injection will be assessed in the study eye. Bulbar conjunctival injection will be assessed based on a 0-4 bulbar conjunctival injection scale which uses pictures from the validated bulbar redness (VBR) scale. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Clinical Signs Score of Watery Conjunctival Discharge [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Individual clinical signs score for watery conjunctival discharge will be assessed in the study eye. Watery conjunctival discharge will be assessed based on a 0-3 watery conjunctival discharge scale. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.
  • Change From Baseline in Clinical Signs Score for Bulbar Conjunctival Injection [ Time Frame: Baseline, Day 3, 6, 8 and 12 ]
    The change from baseline in clinical signs score for bulbar conjunctival injection will be assessed. Bulbar conjunctival injection will be assessed based on a 0-4 bulbar conjunctival injection scale which uses pictures from the validated bulbar redness (VBR) scale.
  • Change From Baseline in Clinical Signs Score for Watery Conjunctival Discharge [ Time Frame: Baseline, Day 3, 6, 8 and 12 ]
    The change from baseline in clinical signs score for watery conjunctival discharge will be assessed. Watery conjunctival discharge will be assessed based on a 0-3 watery conjunctival discharge scale.
  • Global Clinical Score [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Global clinical score is the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.
  • Change From Baseline in Global Clinical Score [ Time Frame: Baseline, Day 3, 6, 8 and 12 ]
    Global clinical score is the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.
  • Proportion of Participants With Modified Clinical Resolution [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Modified clinical resolution is defined as a global clinical score of 0 or 1 in the study eye. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Proportion of Participants With Expanded Clinical Resolution [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Expanded clinical resolution is defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2 in the study eye. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Proportion of Participants With Cross-Over Infection as Assessed by Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Baseline, Day 3, Day 6, Day 8 and Day 12 ]
    The cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline will be assessed. The CC-IFA for each eye will be conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.
  • Time to Clinical Resolution [ Time Frame: Baseline up to Day 12 ]
    Time to clinical resolution of adenoviral conjunctivitis will be analysed in the study eye. The study eye is defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration up to Day 14 ]
    An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
Adenoviral Eradication Between SHP640 and Placebo as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 6 ]
Not Provided
Not Provided
 
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo
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 Adenoviral Conjunctivitis
The purpose of this study is to determine the efficacy and safety of SHP640 compared with placebo in the treatment of participants with adenoviral conjunctivitis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Adenoviral Conjunctivitis
  • Drug: SHP640
    Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
  • Drug: Placebo
    Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
  • Experimental: SHP640
    Participants instructed to instill 1 drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
    Intervention: Drug: SHP640
  • Placebo Comparator: Placebo
    Participants instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
284
Same as current
November 1, 2019
November 1, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
  2. 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.
  3. Participants of any age at Visit 1 (Note: Participants less than (<) 3 months of age at Visit 1 must have been full-term, that is greater than or equal to (>=) 37 weeks gestational age at birth).
  4. 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 (example: 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 1 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 4a (a positive AdenoPlus test in at least 1 eye), then the same eye must meet Inclusion Criterion 5.

  5. 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: Report presence of signs and/or symptoms of adenoviral conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1; Bulbar conjunctival injection: a grade of >=1 on 0-4 scale of Bulbar Conjunctival Injection Scale; Watery conjunctival discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale.
  6. Be willing to discontinue contact lens wear for the duration of the study.
  7. 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 American Academy of Pediatrics (AAP) Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians. 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.
  8. 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

  1. 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.
  2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
  3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  4. Prior enrollment in a FST-100 or SHP640 clinical study.
  5. Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  6. Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study.
  7. Have a preplanned overnight hospitalization during the period of the study.
  8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example: uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
  9. Have presence of corneal subepithelial infiltrates at Visit 1.
  10. Have active or history of ocular herpes.
  11. 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 (example: bacterial, fungal, acanthamoebal, or other parasitic).

    Note: History or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.

  12. Neonates or infants (that is (ie,) participants < 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.
  13. Neonates or infants (ie, participants < 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
  14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
  15. Presence of any significant ophthalmic condition (example: retinopathy of prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
  16. Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma, or be a glaucoma suspect.
  17. Have any known clinically significant optic nerve defects.
  18. 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.
  19. Presence of significant, active condition in the posterior segment which requires invasive treatment (example: intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
  20. Have used any topical ocular or systemic anti-virals or antibiotics within <= 7 days of enrollment.
  21. Have used any topical ocular NSAIDs within <= 1 day of enrollment.
  22. Have used any topical ophthalmic steroids in the last <= 14 days.
  23. 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.
  24. Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
  25. 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.
  26. Have any significant ocular disease (example: Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (example: cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per investigator's discretion.
  27. 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.
  28. Within 30 days prior to the first dose of investigational product: Have used an investigational product or device, or Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@Shire.com
Puerto Rico,   United States
 
 
NCT02998554
SHP640-302
2016-002440-16 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Shire
Shire
Not Provided
Study Director: Shire Study Physician Shire
Shire
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP