Clinical Trial: Treatment of Adenoviral Conjunctivitis With SHP640 Compared to 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 Placebo in th

Brief Summary: The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

• Clinical Resolution Status of SHP640 and Placebo as Measured by Bulbar Conjunctival Injection [ Time Frame: Day 6 ]
  Clinical resolution of adenoviral conjunctivitis is defined as the absence (score=0) of bulbar conjunctival injection. 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.
• Clinical Resolution Status of 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 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. Watery conjunctival discharge will be assessed based on a 0-3 scale.

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

Current Secondary Outcome:

• 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. 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at base line as well as his/he r CC-IFA results at baseline.
• 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 sample s 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 3, Day 8 and Day 12 ]
  Adenoviral eradication for the study eye is defined as negative CC-IFA in that eye. 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 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.
• 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 Day 12 ]
  Global clinical score is the sum of bulbar conjunctival injection and watery conjunctival discharge. 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.
• Change From Baseline in the 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. 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.
• 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
• 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 subject's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
• Time to Clinical Resolution [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
  Time to clinical resolution based upon assessments will be analysed 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.
• Status of Cross-over Infection [ Time Frame: Day 3, Day 6, Day 8 and Day 12 ]
  The status of cross-over infection which is assessed by CC-IFA to a subject's fellow eye will be for subjects with only 1 infected eye at baseline.
• Safety and Tolerability of SHP640 as measured by adverse events (AEs) [ Time Frame: Day 1 up to Day 13 ]
  Safety and tolerability of SHP640, compared to placebo will be evaluated in the treatment of subjects with adenoviral conjunctivitis.

Original Secondary Outcome: Adenoviral Eradication Between SHP640 and Placebo as Measured by Negative Cell Culture-Immunofluorescence Assay (CC-IFA) [ Time Frame: Day 6 ]

Information By: Shire

Dates:
Date Received: December 16, 2016
Date Started: March 31, 2017
Date Completion: May 1, 2018
Last Updated: May 8, 2017
Last Verified: May 2017