Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

Thea Pharma

Status and phase: Completed; Phase 2

Conditions: Acute Adenoviral Keratoconjunctivitis

Treatments: Drug: placebo; Drug: GV550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01156025

LTGV550-PII-11/06

2007-002455-16 (EudraCT Number)

Details and patient eligibility

About

The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

GV550

Experimental group

Description:

(Ganciclovir 1.5 mg/g ophtalmic gel)

Treatment:

Drug: GV550

Placebo

Placebo Comparator group

Description:

Placebo ophtalmic gel

Treatment:

Drug: placebo