Clinical trial NCT02199327: Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia
Official title: Clinical Trial to Compare Topical Interferon Alfa 2b And Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conjunctival Intraepithelial Neoplasia
Corneal Intraepithelial Neoplasia
Keywords: Conjunctival-corneal intraepithelial neoplasia
Mitomycin C
Interferon alfa 2b
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
name: University of Guadalajara
First posted: 2014-07-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial neoplasia.

Detailed description: The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of the ocular surface. Classic treatment is complete excision with safety margins, however, usually the edges are not sharp and difficult clinical differentiation between healthy areas that are not; to this treatment has joined him carrying out cryotherapy bedding and borders . Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been used either as adjuvant or primary treatment . Among the drugs used the investigators have mitomycin C (MMC) and interferon alpha 2b (INFα 2b).

Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined.

Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).

Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of corneal and conjunctival intraepithelial neoplasia (CIN) with no history of ocular neoplasia

Exclusion Criteria:

* Patients who did not agree to participate in the study.
* Patients with corneal abrasion
* Patients who have the diagnosis of CIN, but are pregnant

Primary outcomes:
measure: Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia
timeFrame: One month to one year
Secondary outcomes:
measure: Adverse effects with topic therapy
timeFrame: One to two years
Other outcomes:
measure: Recurrence of conjunctival-corneal intraepithelial neoplasia
timeFrame: One year
Locations:
city: Guadalajara
country: Mexico
facility: IMSS Centro Médico de Occidente
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Alvarado Beatriz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: