Intraepithelial neoplasia of the conjunctiva.
Conditions
Interventions
Group I (study): Administration of recombinant interferon eye drops, by topical route (ocular), one drop (in the operated eye) every 4 hours for 30 days. Group II (control): Administration of placebo
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Not aplicable.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Histological diagnosis of intraepithelial neoplasia of the conjunctiva. 2) Age between 18 and 75, inclusive. 3) Voluntariness of the patient by signing the Informed Consent.
Exclusion criteria
Exclusion criteria: 1) Patients who present at diagnosis, inflammatory and infectious eye diseases such as uveitis active, severe corneal ulcer and endophthalmitis. 2) bilateral tumor lesion of the ocular conjunctiva. 3) hypersensitivity to IFN or other component of the formulation. 4) antiviral treatment (including IFN via any route) in the last 30 days. 5) Pregnancy or lactation at the time of inclusion in the study. 6) Mental incapacity to give consent clearly and act accordingly to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Tumor recurrence (defined as the appearance of tumorous lesion in the first year post-surgery [if it occurs in the first 6 months is considered early recurrence, after 6 months, late recurrence]). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to recurrence (days, months). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). - Occurrence of complications (Yes, No, type, severity, causal relationship to study treatment). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). - Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). | — |
Countries
Cuba
Contacts
Public ContactDr. Odalys Lazo Diago
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed