Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01156025

Enrollment

Registered

2010-07-02

Start date

2009-03-31

Completion date

2010-06-30

Last updated

2010-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Adenoviral Keratoconjunctivitis

Keywords

GV550, Acute adenoviral keratoconjunctivitis

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.

Interventions

DRUGGV550

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)

DRUGplacebo

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
efficacy of GV550	D0 to D4	* The evolution of the inflammation * The virus load by quantitative PCR

Secondary

Measure	Time frame	Description
efficacy of GV550	—	* The assessment of the patient's symptomatology evaluation * The score of each subjective signs * The score of each objective signs * The occurrence of focal corneal sub epithelial infiltrates (nummular stromal infiltration) * The occurrence of pseudo membranes * The virus load between D0-D10
Ocular safety	—	* To compare the ocular tolerance of GV550 eye drops versus placebo eye drops with respect of the assessment of the global local tolerance assessment by the investigator and by the patient * To compare the ocular safety of GV550 eye drops versus placebo eye drops with respect of the assessment of the best corrected far visual acuity and ocular Adverse Event (AE) reporting at each visit
Systemic safety	—	\- To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026