Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01156025
First received: June 30, 2010
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Acute Adenoviral Keratoconjunctivitis
Drug: GV550
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • efficacy of GV550 [ Time Frame: D0 to D4 ] [ Designated as safety issue: No ]
    • The evolution of the inflammation
    • The virus load by quantitative PCR


Secondary Outcome Measures:
  • efficacy of GV550 [ Designated as safety issue: No ]
    • 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 [ Designated as safety issue: Yes ]
    • 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 [ Designated as safety issue: Yes ]
    - To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit


Enrollment: 16
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GV550
(Ganciclovir 1.5 mg/g ophtalmic gel)
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)
Placebo Comparator: Placebo
Placebo ophtalmic gel
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156025

Locations
France
Medical Director
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
  More Information

No publications provided

Responsible Party: Medical Director, Laboratoires Théa
ClinicalTrials.gov Identifier: NCT01156025     History of Changes
Other Study ID Numbers: LTGV550-PII-11/06, 2007-002455-16
Study First Received: June 30, 2010
Last Updated: July 1, 2010
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Laboratoires Thea:
GV550
Acute adenoviral keratoconjunctivitis

Additional relevant MeSH terms:
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on September 11, 2014