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OpenTrials
Completed

NCT Number: NCT01156025

Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

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

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Key information

Conditions

Acute Adenoviral Keratoconjunctivitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Director

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GV550

Drug

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)

Placebo

Drug

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)

Primary outcomes

  1. efficacy of GV550

    Time frame: D0 to D4

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2010
Registry last updated
Jul 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.