NCT01156025

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Adenoviral Keratoconjunctivitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-02-01
• Completion: 2010-06-01
• First posted: 2010-07-02
• Last updated: 2010-07-02

Locations

1 site across 1 country: France