Last updated on September 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adenoviral Conjunctivitis
  • Age: - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Subjects of any age at Visit 1.
  2. Have a positive AdenoPlus test at Visit 1 in at least 1 eye.
  3. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye.
  4. Be willing to discontinue contact lens wear for the duration of the study.
  5. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
  6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  1. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  2. Prior enrollment in a FST100 or SHP640 clinical study.
  3. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  4. Have a history of ocular surgical intervention within 6 months prior to Visit 1 or planned for the period of the study.
  5. Have a preplanned overnight hospitalization during the period of the study.
  6. Have active or history of ocular herpes.
  7. 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 (eg, bacterial, fungal, acanthamoebal, or other parasitic).
  8. Other protocol defined exclusion criteria may apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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