Subjects in this group will be treated with eye drops containing a 10% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.

Subjects in this group will be treated with eye drops containing a 20% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.

Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)

Fuchs Endothelial Corneal Dystrophy

N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.

N-acetyl cysteine (NAC) 10% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.

N-acetyl cysteine (NAC) 20% solution

Visine Tears Dry Eye Relief artificial tears ophthalmic solution

Visine Dry Eye Relief eye drops

Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

The primary endpoint is the level of H2O2 in the aqueous humor obtained at time of DMEK surgery.

Safety assessment will be ongoing for the entire 28 days that study participants take study drug (prior to surgery) and in all post surgical follow-up visits. Assessment will be based on the number and severity of adverse events, with specific scrutiny for evidence of severe ocular adverse reactions such as ocular chemosis, severe injection, presence or worsening of corneal epithelial staining and/or epithelial defects.

Participants will be asked to fill out a tolerability and medication adherence questionnaire where they will rate the irritation, burning, itchiness and redness they experience after using the medication on a scale of 1 to 100.

Change in patient-reported visual disability will be obtained using the previously validated questionnaire, V-FUCHS instrument 10 before and after the study drug is administered. Participants will be asked how often they experience specific visual difficulties selecting from the following choices: never, rarely, sometimes, most of the time or all of the time. Participants will also be asked how much difficulty they have performing certain visual tasks. Options for the answers are: No difficulty, a little difficulty, moderate difficulty, a lot of difficulty or extreme difficulty.

Change in central corneal thickness as measured by CCT; decrease by >30 µm before and after NAC drop administration period.

Change in the number of corneal endothelial cells as determined by HRT3 with Rostock Corneal Module (Heidelberg Engineering, Heidelberg, Germany) before and after NAC drop administration period. If central counts are unattainable due to end-stage of FECD, then peripheral counts will be obtained.

Corneal tomography is a three-dimensional imaging technique that characterizes the anterior/posterior corneal surfaces. Participants will have corneal tomography twice: first before they start the study drug, and then again, 28 to 42 days later when the drug treatment has concluded. Change in corneal tomography imaging will be assessed qualitatively.

Ula Jurkunas

Associate Professor, Harvard Medical School

Massachusetts Eye and Ear Infirmary

Initially, 16 participants will be randomized 1:1 to one of two groups, a group administering N-acetyl cysteine (NAC) 10% and a group administering Visine Tears Dry Eye Relief artificial tears ophthalmic solution (the placebo).
After interim analysis of the study with 16 participants, if a significant difference in the primary endpoint between NAC 10% and placebo is not found, an additional 17 participants will be enrolled to investigate 20% NAC. In this case, 11 additional participants will be enrolled to receive NAC 20%, an additional 3 participants will receive NAC 10%, and an additional 3 participants will receive placebo.

This is a double-blind trial, where neither the study participant nor the investigators know which treatment group the study participant has been assigned to.

apply 2 drops to 2 target nails under occlusion daily for 20 weeks

apply to target nails daily under occlusion daily for 20 weeks

Cyclosporine Solution

Vehicle

Total

Sex: Female, Male

Region of Enrollment

IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails

• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.

the percentages of participants who were satisfied with the "length of fingernails"

Patients Assessment of Satisfaction With Length of Fingernails

Topical Cyclosporine 0.05% Ophthalmic Suspension

Cyclosporine Solution 0.05% (Restasis®)

Topical vehicle: Refresh Dry Eye Therapy® (ophthalmic solution of glycerin 1% and polysorbate 80 1%)

Vehicle (Refresh Dry Eye Therapy®)

Overall Study

Aida Lugo-Somolinos MD

Brittle Nail Syndrome

apply 2 drops to 2 target fingernails under occlusion daily

topical cyclosporine ophthalmic suspension 0.05%

apply 2 drops to 2 target fingernails under occlusion daily for 20 weeks

vehicle

University of North Carolina

Topical Cyclosporine Suspension for the Treatment of Brittle Nails

A Single Center, Investigator-blinded Study of the Efficacy of Topical Cyclosporine 0.05% Ophthalmic Suspension (RESTASIS®) Under Occlusion Versus Vehicle in the Treatment of Brittle Nail Syndrome

keratoconjunctivitis sicca/l tsüsteiin

Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

Topical Cyclosporine Suspension for the Treatment of Brittle Nails

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