E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
herpetic dendritic keratitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019998 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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 time course of severity of disease-related 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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
1 mese dopo l`arruolamento dell`ultimo paziente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |