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Mitomycin-C for Corneal Opacity

Phase 2 & 3

Waitlist Available

Led By John B Cason, M.D.

Research Sponsored by United States Naval Medical Center, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing whether using mitomycin-C during PRK surgery, and tapering off steroids either 3 weeks or 1 week post-op, is as effective as the more commonly used 2 month post-op steroid taper regimen, in terms of refractive error and haze formation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Corneal haze

Refractive Error

Side effects data

From 2017 Phase 2 trial • 100 Patients • NCT02016898

31%

Wound leak

31%

Hypotony

11%

Cystic blebs

Choroidal effusion

Shallowing of anterior chamber

Hyphema

Suprachoroidal hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Irrigation Placement of Mitomycin-C

Sponge Placement of Mitomycin-C

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mitomycin-C; 3 week FML steroid taperExperimental Treatment2 Interventions

Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 3 week fluorometholone 1% topical steroid taper.

Group II: Mitomycin-C; 1 week FML steroid taperExperimental Treatment2 Interventions

Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 1 week of fluorometholone 1% topical steroid.

Group III: No mitomycin-C; 8 week FML steroid taperActive Control1 Intervention

No mitomycin-C will be administered during the procedure. Instead a sham application of salt solution will be given for 15 seconds. The patient will take 8 weeks of topical fluorometholone 1% topical steroid drop taper.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitomycin-C

2011

Completed Phase 2

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor

102 Previous Clinical Trials

22,416 Total Patients Enrolled

John B Cason, M.D.Principal InvestigatorUnited States Naval Medical Center, San Diego

Donna Murdoch, Ph.D.Study DirectorNavy Warfighter Refractive Surgery San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this trial extend beyond 75 years old?

"The minimum age limit for potential participants of this research is 21 years old and the maximum is 65."

Answered by AI

For what sorts of illnesses is Mitomycin-C most often prescribed?

"In addition to non-small cell lung carcinoma, mitomycin-C is an effective treatment option for conditions like inflammation corneal, cancer, anal, and allergic conjunctivitis."

Answered by AI

What are the requirements to Sign Up for this clinical trial?

"This study is seeking 300 participants who are currently suffering from corneal opacity and fall between the ages of 21 and 65. In addition to meeting this age criteria, it is important that potential participants also meet the following contact lens use, visual acuity, refraction, and follow-up requirements: Soft contact lenses must have been removed at least two (2) weeks prior to baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four (4) weeks prior to baseline measurements., Manifest spherical equivalent (MSE) from +3.00 D to -11"

Answered by AI

To what other research projects has Mitomycin-C been integral?

"At this time, there are a total of 46 studies being conducted that involve Mitomycin-C. Of these ongoing research projects, 13 are in Phase 3. Many of the investigations being done for Mitomycin-C are based out of Bethesda, Maryland; however, there are 2071 total locations running trials for this medication."

Answered by AI

Are people with this medical condition currently being enrolled in this research study?

"Unfortunately, this particular clinical trial is not recruiting patients at this time. The trial was originally posted on August 1st, 2014 but was last updated on April 14th, 2022. With that said, there are 50 other trials that are actively looking for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements

John Cason 2014. "The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02030990.