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

Primary Purpose

Conjunctival Intraepithelial Neoplasia, Corneal Intraepithelial Neoplasia

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Mitomycin C
Interferon Alfa-2b
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctival Intraepithelial Neoplasia focused on measuring Conjunctival-corneal intraepithelial neoplasia, Mitomycin C, Interferon alfa 2b

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IMSS Centro Médico de Occidente

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mitomycin C

Interferon alfa 2b

Arm Description

Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).

Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor

Outcomes

Primary Outcome Measures

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

Adverse effects with topic therapy
Watch as topical treatment is maintained and at least one years after the resolution of the lesion.

Full Information

First Posted
July 8, 2014
Last Updated
August 7, 2017
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social, University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT02199327
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 16, 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social, University of Guadalajara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctival Intraepithelial Neoplasia, Corneal Intraepithelial Neoplasia
Keywords
Conjunctival-corneal intraepithelial neoplasia, Mitomycin C, Interferon alfa 2b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mitomycin C
Arm Type
Active Comparator
Arm Description
Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).
Arm Title
Interferon alfa 2b
Arm Type
Active Comparator
Arm Description
Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Other Intervention Name(s)
Mutamycin, Mitomycin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Interferon Alfa-2b
Other Intervention Name(s)
Urifron, Intron A
Intervention Description
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
Primary Outcome Measure Information:
Title
Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia
Description
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.
Time Frame
One month to one year
Secondary Outcome Measure Information:
Title
Adverse effects with topic therapy
Description
Watch as topical treatment is maintained and at least one years after the resolution of the lesion.
Time Frame
One to two years
Other Pre-specified Outcome Measures:
Title
Recurrence of conjunctival-corneal intraepithelial neoplasia
Description
Watch at least one year after the resolution of the lesion to detect recurrence.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvarado Beatriz, M.D.
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMSS Centro Médico de Occidente
City
Guadalajara
State/Province
Jalisco
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
we intend to publish the results as a scientific article with all results of participants

Learn more about this trial

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

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