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

• Conditions: herpetic dendritic keratitis; MedDRA version: 9.1Level: LLTClassification code 10019998

• Registration Number: EUCTR2009-010971-26-IT
• Lead Sponsor: MENARINI RICERCHE S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-30
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 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 (i.e. less than 1% per year); 2. 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 by slit lamp examination; onset of signs and symptoms less than 7 days preceding diagnosis/randomisation; 3. Able to give written informed consent before any study related procedure; 4. 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

1. Patients with any stromal infiltrations/lesions, anterior chamber involvement, or any affection of deeper structures of the eye (e.g. keratouveitis); 2. Patients suffering from any disease limiting eye lid closure function such as eye lid deformities, exophthalmus, facial palsy; 3. Patients with bilateral herpetic keratitis; 4. Patients with any corneal or conjunctival bacterial superinfection of the affected eye; 5. Patients with a visual acuity of the contralateral, unaffected eye of 6/60 (20/200) or less; 6. Patients with an intraocular pressure > 30 mmHg in the affected eye ; 7. Patients having received local antiherpetic treatment (local antivirals and/or local steroids) within 8 weeks prior to study entry; 8. Patients who received systemic antiviral therapy within 1 month prior to study entry; 9. Patients under immunosuppressive therapy, including continuous treatment with systemic steroids; 10. Patients who underwent tissue transplantation (e.g. amniotic membrane transplantation or keratoplasty [PKP]); 11. Patients with a history of recurrences of epithelial herpetic keratitis known to be caused by HSV-2; 12. Patients with a history of hypersensitivity to aciclovir; 13. Patients with a history of hypersensitivity to brivudin; 14. Patients with known HIV infection; 15. Patients treated and/or planned to be treated with any 5-fluoropyrimidines (e.g. 5-FU, tegafur, capecitabin, or flucytosin) within 1 month prior to study entry and/or after study entry; 16. 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); 17. Pregnant or breast feeding women; 18. Patients who received any other investigational agent within 30 days prior to study entry; 19. Patients not suitable for adequate follow up.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified