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Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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