Clinical Trial: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

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

Official Title: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x

Brief Summary: The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.

Detailed Summary:
Sponsor: Laboratoires Thea

Current Primary Outcome: efficacy of GV550 [ Time Frame: D0 to D4 ]

  • The evolution of the inflammation
  • The virus load by quantitative PCR


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • efficacy of GV550
    • The assessment of the patient's symptomatology evaluation
    • The score of each subjective signs
    • The score of each objective signs
    • The occurrence of focal corneal sub epithelial infiltrates (nummular stromal infiltration)
    • The occurrence of pseudo membranes
    • The virus load between D0-D10
  • Ocular safety
    • To compare the ocular tolerance of GV550 eye drops versus placebo eye drops with respect of the assessment of the global local tolerance assessment by the investigator and by the patient
    • To compare the ocular safety of GV550 eye drops versus placebo eye drops with respect of the assessment of the best corrected far visual acuity and ocular Adverse Event (AE) reporting at each visit
  • Systemic safety
    - To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit


Original Secondary Outcome: Same as current

Information By: Laboratoires Thea

Dates:
Date Received: June 30, 2010
Date Started: March 2009
Date Completion:
Last Updated: July 1, 2010
Last Verified: July 2010