A Phase II trial comparing Brivudin 0.1% ophthalmic solution with Aciclovir 3 % ophthalmic ointment in the treatment of patients with herpetic dendritic keratitis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

-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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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