Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

Acute Adenoviral Keratoconjunctivitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156025
• Other study ID #: LTGV550-PII-11/06
• Secondary ID: 2007-002455-16
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2010
• Last updated: July 1, 2010
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Adenoviral Keratoconjunctivitis
• Keratoconjunctivitis

Intervention

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
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)

Locations

Country	Name	City	State
France	Medical Director	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of GV550	The evolution of the inflammation; The virus load by quantitative PCR	D0 to D4	No
Secondary	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		No
Secondary	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		Yes
Secondary	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		Yes