Back to resultsEfficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
Primary Purpose
Acute Adenoviral Keratoconjunctivitis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
GV550
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Adenoviral Keratoconjunctivitis focused on measuring GV550, Acute adenoviral keratoconjunctivitis
Eligibility 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
Sites / Locations
- Medical Director
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GV550
Placebo
Arm Description
(Ganciclovir 1.5 mg/g ophtalmic gel)
Placebo ophtalmic gel
Outcomes
Primary Outcome Measures
efficacy of GV550
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156025
Brief Title
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Adenoviral Keratoconjunctivitis
Keywords
GV550, Acute adenoviral keratoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GV550
Arm Type
Experimental
Arm Description
(Ganciclovir 1.5 mg/g ophtalmic gel)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo ophtalmic gel
Intervention Type
Drug
Intervention Name(s)
GV550
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
efficacy of GV550
Description
The evolution of the inflammation
The virus load by quantitative PCR
Time Frame
D0 to D4
Secondary Outcome Measure Information:
Title
efficacy of GV550
Description
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
Title
Ocular safety
Description
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
Title
Systemic safety
Description
- To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical Director
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
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