acute adenoviral keratoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10014975 Term: Epidemic keratoconjunctivitis
Conditions
Interventions
Trade Name: Virgan
Product Name: Virgan
Product Code: GV 550
Pharmaceutical Form: Eye gel
INN or Proposed INN: Ganciclovir
CAS Number: 82410-32-0
Concentration unit: mg/g milligram(s)/gram
Concentrati
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent Male or female aged from 18 to 80 years old Acute adenoviral keratoconjunctivitis clinically diagnosed on the basis of: • First episode • With an history of unilateral occurrence • Recent (first symptoms lasting less than 3 days) • Conjunctival injection • Tearing • Without infiltrates • Without purulent secretion • With positive rapid test diagnosis (RPS Adeno-detector®) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Active ocular allergy, Ocular herpes disease •History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit •Any relevant ocular anomaly interfering with ocular surface: chemical burns, corneal distrophy, orbital radiotherapy, progressive involvement after traumatism, etc……. •Best far corrected visual acuity = 1/10 •By questioning: Any known medical or surgical history, disorder or disease such as acute or chronic severe organic disease •Known hypersensitivity to one of the components of the study products. •Pregnancy, lactation for women •Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance, man who is not using a local contraceptive method such as condom).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of GV 550 versus placebo to treat acute adenoviral keratoconjunctivitis •2 primary criteria will be assessed (evolution between D0 and D4) : - Evolution of the inflammation assessed by subjective signs score (tearing + foreign body sensation + photophobia) and objective signs score (conjunctival injection + conjunctival chemosis + punctate epithelial keratitis) - Viral load by quantitative PCR. ;Secondary Objective: • Other assessed criteria: - Patient’s symptomatology evaluation (VAS) - Score of each subjective signs (tearing, foreign body sensation, photophobia, pain, itching) - Score of each objective signs (NEI score, Van bijsterveld score, BUT , Schirmer test values, Slit lamp examination) - Existancy of focal corneal subepithelial infiltrates (nummular stromal infiltration) - Existancy of pseudo-membranes - Virus load between D0-D10 ;Primary end point(s): The primary variable is the change between Day 0 and Day 4 (value at Day 4 minus value at Day 0) of the inflammation for both eyes assessed by subjective signs score (tearing + foreign body sensation + photophobia) and objective signs score (conjunctival injection + conjunctival chemosis + punctate epithelial keratitis). | — |
Countries
Germany
Outcome results
None listed