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Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156025
First Posted: July 2, 2010
Last Update Posted: July 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laboratoires Thea
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • efficacy of GV550 [ Time Frame: D0 to D4 ]
    • The evolution of the inflammation
    • The virus load by quantitative PCR


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156025


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

Responsible Party: Medical Director, Laboratoires Théa
ClinicalTrials.gov Identifier: NCT01156025     History of Changes
Other Study ID Numbers: LTGV550-PII-11/06
2007-002455-16 ( EudraCT Number )
First Submitted: June 30, 2010
First Posted: July 2, 2010
Last Update Posted: July 2, 2010
Last Verified: July 2010

Keywords provided by Laboratoires Thea:
GV550
Acute adenoviral keratoconjunctivitis

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