Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

Overview

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

Full Title of Study: “Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2×40 Patients)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2010

Interventions

  • Drug: GV550
    • Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
  • Drug: placebo
    • 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)

Arms, Groups and Cohorts

  • Experimental: GV550
    • (Ganciclovir 1.5 mg/g ophtalmic gel)
  • Placebo Comparator: Placebo
    • Placebo ophtalmic gel

Clinical Trial Outcome Measures

Primary Measures

  • efficacy of GV550
    • Time Frame: D0 to D4
    • The evolution of the inflammation The virus load by quantitative PCR

Secondary Measures

  • efficacy of GV550
  • Ocular safety
  • Systemic safety

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent – Male or female aged from 18 to 80 years old – Acute adenoviral keratoconjunctivitis Exclusion Criteria:

  • Active ocular allergy – Ocular herpès disease – History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laboratoires Thea
  • Provider of Information About this Clinical Study
    • Medical Director, Laboratoires Théa

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