NCT01156025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
Last Updated

July 2, 2010

Status Verified

July 1, 2010

Enrollment Period

11 months

First QC Date

June 30, 2010

Last Update Submit

July 1, 2010

Conditions

Acute Adenoviral Keratoconjunctivitis

Keywords

GV550Acute adenoviral keratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • efficacy of GV550

    * The evolution of the inflammation * The virus load by quantitative PCR

    D0 to D4

Secondary Outcomes (3)

  • efficacy of GV550

  • Ocular safety

  • Systemic safety

Study Arms (2)

GV550

EXPERIMENTAL

(Ganciclovir 1.5 mg/g ophtalmic gel)

Drug: GV550

Placebo

PLACEBO COMPARATOR

Placebo ophtalmic gel

Drug: placebo

Interventions

GV550DRUG

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)

GV550
placeboDRUG

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Male or female aged from 18 to 80 years old
  • Acute adenoviral keratoconjunctivitis

You may not qualify if:

  • Active ocular allergy
  • Ocular herpès disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Director

Clermont-Ferrand, 63000, France

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

July 2, 2010

Record last verified: 2010-07

Locations

FR(1)