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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.