Clinical Trial: Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Acute Phase Adenoviral-Induced Epidemic Keratoconjunctivitis (EKC). A Randomised, Double-Masked, Placebo-Controlled, Multi-C

Brief Summary: A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical resolution of EKC (objective and subjective assessments), presence of opacities, visual acuity and frequency of second eye infections, and to assess the safety and tolerability of APD-209 Eye drops in EKC infected eyes.

Detailed Summary:
Sponsor: Adenovir Pharma AB

Current Primary Outcome: The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ]

Viral load in tear liquid from EKC infected eyes, as measured by the area under the curve (AUC) at 3-14 days from start of treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ]
    The time point of viral eradication in tear liquid from EKC infected eyes, defined as the time Point when viral load=0 or below the lower limit of quantification (LLOQ).
  • Evaluate the effect of APD-209 Eye drops on clinical resolution of EKC, as measured by objective and subjective assessment of scaled clinical symptoms, compared to placebo. [ Time Frame: 14 days ]
    Resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness.
  • Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ]
    Presence and location of opacities at each time of assessment, as measured by slit lamp examination.
  • Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 28 days ]
    Visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart.
  • Assess the frequency of second eye infections. [ Time Frame: 14 days ]
    Occurrence of second eye infection.
  • Assess the safety and tolerability of APD-209 Eye drops. [ Time Frame: 14 days ]
    Safety variables: adverse events (AEs) (nature and incidence), Physical examination, vital signs, laboratory safety assessments (haematology, clinical chemistry and urinalysis)


Original Secondary Outcome: Same as current

Information By: Adenovir Pharma AB

Dates:
Date Received: October 31, 2013
Date Started: November 2013
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016