Herpetic dendritic keratitis MedDRA version: 12.0 Level: LLT Classification code 10012307 Term: Dendritic keratitis
Conditions
Interventions
Product Name: brivudin 0.1% eye drops
Product Code: brivudin
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Brivudin
CAS Number: 69304-47-8
Concentration unit: % (V/V) percent volume/vo
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female Caucasian patients between 18 and 80 years of age. A female of childbearing potential may be enrolled providing she: • has a negative pregnancy test at baseline and • is routinely using a highly effective method of birth control resulting in a low failure rate; -Patients with clinically verified diagnosis of unilateral herpetic dendritic keratitis, either as primary episode or recurrence, showing all of the following: • characteristic corneal lesions due to herpetic dendritic keratitis evidenced by fluorescein staining in slit lamp examination; • onset of signs and symptoms less than 7 days preceding diagnosis/randomisation; -Able to give written informed consent before any study related procedure; -Able to attend all the visits scheduled in the study. 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: -Patients with any stromal infiltrations/lesions, anterior chamber involvement, or any affection of deeper structures of the eye (e.g. keratouveitis); -Patients suffering from any disease limiting eye lid closure function such as eye lid deformities, exophthalmus, facial palsy; -Patients with bilateral herpetic keratitis; -Patients with any corneal or conjunctival bacterial superinfection of the affected eye; -Patients with a visual acuity of the contralateral, unaffected eye of 6/60 (20/200) or less; -Patients with an intraocular pressure > 30 mmHg in the affected eye ; -Patients having received local antiherpetic treatment (local antivirals and/or local steroids) within 8 weeks prior to study entry; -Patients who received systemic antiviral therapy within 1 month prior to study entry; -Patients under immunosuppressive therapy, including continuous treatment with systemic steroids; -Patients who underwent tissue transplantation (e.g. amniotic membrane transplantation or keratoplasty [PKP]); -Patients with a history of recurrences of epithelial herpetic keratitis known to be caused by HSV-2; -Patients with a history of hypersensitivity to aciclovir; -Patients with a history of hypersensitivity to brivudin; -Patients with known HIV infection; -Patients treated with any 5-fluoropyrimidines (e.g. 5-FU, tegafur, capecitabin, or flucytosin) within 1 month prior to study entry; -Patients with any serious intercurrent illness which, in the opinion of the Investigator, is incompatible with the protocol (e.g. systemic infections, sepsis, severe atopic diseases, malignant diseases); -Pregnant or breast feeding women; -Patients who received any other investigational agent within 30 days prior to study entry; -Patients not suitable for adequate follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of brivudin 0.1% ophthalmic solution with aciclovir 3.0 % ophthalmic ointment in the healing (corneal re-epithelialisation) of herpetic dendritic keratitis.;Secondary Objective: to compare the efficacy of brivudin 0.1% ophthalmic solution with aciclovir 3.0 % ophthalmic ointment in the treatment of herpetic dendritic keratitis with regard to: -the proportion of patients healed by days 5, 7, 10 and 14 -the time to resolution of ocular symptoms -the severity of ocular symptoms -the incidence of early relapses of herpetic keratitis (within 14 days after start of treatment) -the incidence of late relapses of herpetic keratitis (within 1 month after start of treatment) -the incidence of treatment discontinuations due to worsening condition or complications to evaluate the tolerability profile of brivudin 0.1% ophthalmic solution versus aciclovir 3.0 % ophthalmic ointment. ;Primary end point(s): Time from start of treatment to healing of corneal lesions, i.e. demonstration of the re-epithelialisation of corneal lesions as evidenced by the absence of fluorescein uptake in the area of the corneal lesion (using blinded assessment by the independent expert) | — |
Countries
Germany, Italy, Spain
Outcome results
None listed