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Completed

NCT Number: NCT02199327

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IMSS Centro Médico de Occidente

Guadalajara, Jalisco, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitomycin C

Drug

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).

Other names: Mutamycin, Mitomycin

Interferon Alfa-2b

Drug

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

Other names: Urifron, Intron A

Primary outcomes

  1. Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia

    Time frame: 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 outcomes

  1. Adverse effects with topic therapy

    Time frame: One to two years

    Watch as topical treatment is maintained and at least one years after the resolution of the lesion.

Other outcomes

  1. Recurrence of conjunctival-corneal intraepithelial neoplasia

    Time frame: One year

    Watch at least one year after the resolution of the lesion to detect recurrence.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Instituto Mexicano del Seguro Social
  • University of Guadalajara

Registry information

Official study title

Clinical Trial to Compare Topical Interferon Alfa 2b And Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 24, 2014
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.