Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
NCT ID: NCT01156025
Last Updated: 2010-07-02
Study Results
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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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2009-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GV550
(Ganciclovir 1.5 mg/g ophtalmic gel)
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
Placebo ophtalmic gel
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)
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)
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)
Eligibility Criteria
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Inclusion Criteria
* Male or female aged from 18 to 80 years old
* Acute adenoviral keratoconjunctivitis
Exclusion Criteria
* Ocular herpès disease
* History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
18 Years
80 Years
ALL
No
Sponsors
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Laboratoires Thea
INDUSTRY
Responsible Party
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Laboratoires Théa
Locations
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Medical Director
Clermont-Ferrand, , France
Countries
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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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