Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

Phase 2

Completed

• Conditions: Acute Adenoviral Keratoconjunctivitis
• Interventions: Drug: GV550; Drug: placebo

• Registration Number: NCT01156025
• Lead Sponsor: Laboratoires Thea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2010-06
• Study First Submitted: 2010-06-30
• Status Verified: 2010-07
• Study First Submitted QC: 2010-07-01
• Last Update Submitted: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GV550	GV550	(Ganciclovir 1.5 mg/g ophtalmic gel)
Placebo	placebo	Placebo ophtalmic gel

Primary Outcome Measures

Name	Time	Method
efficacy of GV550	D0 to D4	* The evolution of the inflammation; * The virus load by quantitative PCR

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Director; 🇫🇷 Clermont-Ferrand, France