Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

NCT ID: NCT01156025

Last Updated: 2010-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Acute Adenoviral Keratoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GV550

(Ganciclovir 1.5 mg/g ophtalmic gel)

Group Type EXPERIMENTAL

GV550

Intervention Type DRUG

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

Placebo ophtalmic gel

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Laboratoires Théa

Locations

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Medical Director

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2007-002455-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LTGV550-PII-11/06

Identifier Type: -

Identifier Source: org_study_id

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