Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

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

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

Study Overview

• Status: Completed
• Conditions: Acute Adenoviral Keratoconjunctivitis
• Intervention / Treatment: Drug: GV550; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Medical Director

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of GV550	The evolution of the inflammation; The virus load by quantitative PCR	D0 to D4

Secondary Outcome Measures

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2010
• Last Update Submitted That Met QC Criteria: July 1, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: GV550; Acute adenoviral keratoconjunctivitis
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Keratoconjunctivitis
• Other Study ID Numbers: LTGV550-PII-11/06; 2007-002455-16 (EudraCT Number)