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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 PVP-Iodine an

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 adenoviral conjunctivitis.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

  • Clinical Resolution Status Between SHP640 and Placebo as Measured by Absence of Bulbar Conjunctival Injection [ 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 subject'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 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.
  • Clinical Resolution Status Between SHP640 and Placebo as Measured by Watery Conjunctival Discharge [ 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 subject'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 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.


Original Primary Outcome: Clinical Resolution Status between SHP640 and Placebo as measured by absence of bulbar conjunctival injection and watery conjjunctival discharge [ Time Frame: Day 6 ]

Current Secondary Outcome:

  • Clinical Resolution Between SHP640 and Povidone-Iodine (PVP-I) as Measured by Absence of Bulbar Conjunctival Injection [ 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 subject'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 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.
  • Adenoviral Eradication Between PVP-I and Placebo as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 3 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Adenoviral Eradication Between SHP640 and Placebo as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 6 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Adenoviral Eradication Between SHP640 and PVP-I as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 6 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Clinical Resolution Between PVP-I and Placebo as Measured by Absence of Bulbar Conjunctival Injection [ 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 subject'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 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.
  • Adenovirus Viral Titer Assessed by Quantitative Polymerase Chain Reaction (qPCR) [ Time Frame: Day 6 and Day 8 ]
    qPCR test will be performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Adenoviral Eradication as Assessed by Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 8 and Day 12 ]
    Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. CCIFA 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Clinical Resolution of Adenoviral Conjunctivitis [ 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 subject'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 scale which uses pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge will be assessed based on a 0-3 scale.
  • Individual Clinical Signs [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
    Individual Clinical Signs for bulbar conjunctival injection and watery conjunctival discharge will be assessed in the study eye. The study eye is defined based on subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
  • Global Clinical Score [ Time Frame: Day 3, Day 6, Day 8 and

    Original Secondary Outcome:

    • Clinical Resolution Between SHP640 and Povidone-iodine (PVP-I) as measured by absence of bulbar conjunctival injection and watery discharge [ Time Frame: Day 6 ]
    • Adenoviral Eradication Between PVP-I and Placebo as measured by negative cell culture- immunoflurescence assay (CC-IFA) [ Time Frame: Day 3 ]
    • Adenoviral Eradication Between SHP640 and placebo as measured by negative CC-IFA [ Time Frame: Day 6 ]
    • Adenoviral Eradication Between SHP640 and PVP-I as measured by negative CC-IFA [ Time Frame: Day 6 ]
    • Clinical Resolution Between PVP-I and placebo as measured by absence of bulbar conjunctival injection and watery discharge [ Time Frame: Day 6 ]


    Information By: Shire

    Dates:
    Date Received: December 16, 2016
    Date Started: March 28, 2017
    Date Completion: May 1, 2018
    Last Updated: May 2, 2017
    Last Verified: May 2017