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Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

NCT01156025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2010-07-02

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2010-06-30

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01156025 on ClinicalTrials.gov