Comparison Between Topical Mitomycin C and Cyclosporine

NCT05627947 | Completed Phase 1 DMC

• 1 other identifier: OMNEYA HEGAZY
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

mitomycine-C Group

ACTIVE COMPARATOR

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

Cyclosporine Group

ACTIVE COMPARATOR

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

artificial eye drops Group

ACTIVE COMPARATOR

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

Interventions

Mitomycin c DRUG

Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery

Also known as: Cyclosporine

Cyclosporine Group; artificial eye drops Group; mitomycine-C Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Pterygium

Interventions

Mitomycin; Cyclosporine

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marwa Zaki, Assist.Prof.

  Department of ophthalmology Faculty of Medicine, Menoufia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: January 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)