Comparison Between Topical Mitomycin C and Cyclosporine

Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery

Pterygium is a disease associated with proliferation of the fibrovascular tissues of the conjunctiva into the cornea and is related to factors such as ultraviolet light exposure, chronic stimulation, inflammation, climate, and genetics.

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Drug: Mitomycin c

Detailed Description

The first line of treatment for primary pterygium is surgical excision, and despite postoperative adjuvant therapy using mitomycin C, cyclosporine, β-irradiation, argon laser, and bevacizumab, recurrence rates remain high .

Mitomycin C is a metabolic inhibitor extracted from Streptomyces caespitosus that inhibits DNA synthesis .

Cyclosporine is an immunosuppressant that selectively suppresses T-helper cells, controls interleukin synthesis and secretion, and inhibits vascular endothelial growth factor (VEGF)

Bevacizumab is an anti-VEGF antibody that inhibits angiogenesis. Each agent has been studied as an adjuvant therapy to inhibit post-surgery pterygium recurrence.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Faculty of Medicine, Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of primary pterygium
• Pterygium size > or equal 2mm (the horizontal length of the tissue from limbus to cornea will be measured by slit lamp biomicroscopy).
• Ocular discomfort refractory to medical treatment.
• Visual loss induced by pterygium.
• Adult Egyptian population

Exclusion Criteria:

• Patients who had recurrent pterygium or allergy to topical Cyclosporine.
• Patients who had allergy from Mitomycin C.
• Pregnant women.
• Patients with uncontrollable systemic diseases such as hypertension, diabetes, or cardiovascular diseases.
• Patients with diseases of the eye surface such as conjunctivitis and keratitis.
• Patients with a history of eye surgery within the previous six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mitomycine-C Group; This is the First Group and consists of !9 Patients and received 0.02% topical mitomycine C , 4 times per day for five days after the surgery.	Drug: Mitomycin c; Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery; Other Names: Cyclosporine
Active Comparator: Cyclosporine Group; This is the Second Group and consists of !9 Patients and received topical 0.05% Cyclosporine, 4 times per day for three months after the surgery.	Drug: Mitomycin c; Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery; Other Names: Cyclosporine
Active Comparator: artificial eye drops Group; This is the Third Group and consists of !9 Patients and received artificial eye drops, 4 times per day for three months after the surgery.	Drug: Mitomycin c; Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery; Other Names: Cyclosporine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative recurrence of pterygium	According to the anterior segment slit lamp examination, grade 0 will be defined as no recurrence; grade 1 will be defined as thin episcleral blood vessels, not accompanied by fibrosis, observed around the excised area; grade 2 will be defined as fibrovascular proliferation limited to the sclera in the area will be excised; grade 3 will be defined as fibrovascular proliferation crossing the corneal limbus. Grades 2 and 3 will be defined as recurrence.	from baseline to 3 months after primary pterygium surgery.

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Study Chair: Marwa Zaki, Assist.Prof., Department of ophthalmology Faculty of Medicine, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Alkylating Agents; Dermatologic Agents; Antibiotics, Antineoplastic; Antifungal Agents; Calcineurin Inhibitors; Mitomycins; Mitomycin; Cyclosporine; Cyclosporins
• Other Study ID Numbers: OMNEYA HEGAZY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No