Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

Phase 4

Completed

• Conditions: Conjunctival Intraepithelial Neoplasia; Corneal Intraepithelial Neoplasia
• Interventions: Drug: Mitomycin C; Drug: Interferon Alfa-2b

• Registration Number: NCT02199327
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Status Verified: 2016-08
• Primary Completion: 2016-12-16
• Study Completion: 2017-07
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitomycin C	Mitomycin C	Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).
Interferon alfa 2b	Interferon Alfa-2b	Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor

Primary Outcome Measures

Name	Time	Method
Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia	One month to one year	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects with topic therapy	One to two years	Watch as topical treatment is maintained and at least one years after the resolution of the lesion.

Trial Locations

Locations (1)

IMSS Centro Médico de Occidente; 🇲🇽 Guadalajara, Jalisco, Mexico