A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

SURF-100 is being studied for the treatment of dry eye disease. SURF-100 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop. The purpose of this research study is to see how well SURF-100 works to treat dry eye and what potential side effects there are, and to compare it with Vehicle (placebo), 0.1% mycophenolic acid (MPA) in Vehicle, 0.3% MPA in Vehicle, 0.01% betamethasone phosphate (BSP) in Vehicle, Restasis and Xiidra. This study will involve about 280-350 study participants age 18 and older at about 40 different research sites in the United States.

Key facts

Study ID

NCT04734197

Run by

Surface Ophthalmics, Inc.

People needed

349

Starts

2021-01-11

Expected to finish

2022-03-25

Last updated by the study team

2025-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults at least 18 years of age at the time of the Screening visit.
• Willing and able to read, sign, and date the informed consent form (ICF) after the nature of the study has been explained and any questions have been answered, and prior to initiation of any study procedures or exams.
• Willing and able to comply with all study procedures and attend all study visits.
• Willing to suspend use of tear substitutes at least 72 hours prior to Visit 2 (Day 0) through Visit 7 (Day 98).
• Best corrected visual acuity (BCVA) of 0.7 log of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1 (Day -14 to Day 0).
• Subject-reported history of dry eye in both eyes.
• Meeting ALL of the following criteria in the same eye at Visit 1 (Day -14 to Day 0) and meeting ALL of the following criteria in the same eye at Visit 2 (Day 0) if Visit 2 is performed >5 days after Visit 1:
• Minimum score of greater than or equal to 5 but less than or equal to 9 on UNC DEMS questionnaire.
• Schirmer Tear Test (with anesthesia) equal to or less than 10 mm, but more than 1 mm.
• TBUT: Equal to or less than 5 seconds
• A negative urine pregnancy test if female and of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy, or bilateral oophorectomy] or post-menopausal [12 months after last menses] or premenarchal) and must have used adequate birth control throughout the study period (through Visit 7 [Day 98]). Adequate birth control is defined as hormonal-oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device; abstinence; or surgical sterilization of male partner.
• Subjects with secondary Sjögren's syndrome (e.g., rheumatoid arthritis, systemic lupus erythematosus) or other autoimmune diseases (e.g., multiple sclerosis, inflammatory bowel disease) are eligible for study consideration provided the subject meets all other inclusion and exclusion criteria, AND are not in a medical state - in the opinion of the principal investigator - that could interfere with study parameters, are not taking systemic/ocular steroids, and are not immunodeficient/immunosuppressed (e.g., receiving systemic immunomodulating or immunosuppressive drugs to manage their baseline medical state).

You may not qualify if…

• Contraindications or known hypersensitivity to the study drug(s), including RESTASIS or XIIDRA, or their components.
• Subjects who are employees or immediate family members of employees at the investigational site.
• Subjects who are members of the same household.
• Any ocular condition that, in the opinion of the investigator, may affect study parameters including, but not limited to, lid margin disorders (e.g., blepharitis including staphylococcal, demodex, or seborrheic; excessive lid laxity, floppy eyelid syndrome, ectropion, entropion), advanced conjunctivochalasis, Salzmann's nodular degeneration, and asthenopia-related conditions, allergic conjunctivitis, glaucoma, diabetic retinopathy, follicular conjunctivitis, iritis, uveitis, wet-exudative age-related macular degeneration, retinal vein occlusion, and/or active ocular inflammation.
• Any condition that could affect trigeminal nerve function including facial or ocular Herpes Zoster/Shingle, a stroke or nerve palsy affecting the eye(s).
• Use of any topical medication and/or antibiotics for the treatment of blepharitis or meibomian gland disease in either eye within 14 days prior to Visit 2 (Day 0).
• Active or history of ocular herpes or any other ocular infection in either eye within the last 30 days prior to Visit 1 (Day -14 to Day 0).
• Unwilling to avoid wearing contact lenses for 7 days prior to Randomization (Visit 2, Day 0) and for the duration of the study period (through Visit 7, Day 98).
• Positive urine pregnancy test at Screening, nursing an infant or planning to become pregnant during the study.
• Any blood donation or significant loss of blood within 56 days of Visit 1 (Day -14 to Day 0).
• Any history of immunodeficiency disorder, human immunodeficiency virus (HIV), positive hepatitis B, C, or evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplant.
• Any medication (oral or topical) known to cause ocular drying that is not administered as a stable dose for at least 30 days prior to Visit 1 (Day -14 to Day 0) and for the duration of the study (Visit 7, Day 98); antihistamines are not allowed at any time during the study.
• Use of prohibited medications (topical, topical ophthalmic and/or systemic, during the appropriate pre-study washout period (see below) and during the study. Prohibited medications include topical cyclosporine or lifitegrast, use of any other ophthalmic medication (e.g., glaucoma medication, topical anti-inflammatory eye drops) for the duration of the study)
• NOTE: Supplements containing omega-3 are allowed if the subject has been taking said supplement for at least 3 months prior to Screening. Subjects are not allowed to begin taking supplements containing omega-3 during the study. The appropriate pre-study washout period is as follows:
• Antihistamines (including ocular): 7 days prior to Visit 1 (Day -14 to Day 0).
• Topical cyclosporine or lifitegrast or omega-3s within 14 days prior to Visit 1 (Day -14 to Day 0).
• Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1 (Day -14 to Day 0).
• Depot-corticosteroids in either eye at least 45 days prior to the first dose of study drug (Day 0)
• All other topical ophthalmic preparations (including artificial tear substitutes other than the study drops): 72 hours prior to Visit 1 (Day -14 to Day 0).
• Introduction of any new, nonsteroidal anti-inflammatory drugs (NSAIDs) including but not limited to topical, systemic (including sleep-aids containing NSAIDs), inhaled, or irrigation solution within 7 days prior to the first dose of study drug. Subjects who are on stable dose of NSAIDs (stable for at least 4 weeks prior to the first dose of study drug) are eligible for participation and should remain on a stable dose throughout the duration of the study (i.e., through Day 98).
• Triamcinolone in either eye at least 90 days prior to the first dose of study drug (Day 0).
• Inhaled, ingested, sublingual, transdermal or topical products containing marijuana, tetrahydrocannabinol (THC) or cannabidiol (CBD) at least 7 days prior to the first dose of study drug (Day 0).
• Systemic pain relievers, analgesics (e.g., pregabalin, gabapentin, opioids) 14 days prior to the first dose of study drug (Day 0).
• Any supplement, prescribed medication or over-the-counter product that the investigator feels may interfere with the study parameters, including homeopathic remedies, analgesics, and pain medication.
• Oral doxycycline within 6 months of first dose of study drug (Day 0).

Where it is running

• Cornea and Cataract Consultants of Arizona PC — Phoenix, Arizona, United States
• Canyon City EyeCare — Azusa, California, United States
• Inland Eye Specialists — Hemet, California, United States
• North Valley Eye Medical Group Inc. — Mission Hills, California, United States
• LoBue Laser and Eye Medical Center — Murrieta, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Sacramento Eye Consultants, A Medical Corporation — Sacramento, California, United States
• The Eye Center of Northern Colorado — Fort Collins, Colorado, United States
• Connecticut Eye Consultants, PC — Danbury, Connecticut, United States
• Florida Eye Microsurgical Institute, Inc. — Boynton Beach, Florida, United States
• Hernando Eye Institute — Brooksville, Florida, United States
• Bowden Eye and Associates — Jacksonville, Florida, United States
• Eye Center of North Florida PA — Panama City, Florida, United States
• International Research Center — Tampa, Florida, United States
• Blue Ocean Clinical Research at The Macula Center — The Villages, Florida, United States
• Coastal Research Associates, LLC — Roswell, Georgia, United States
• Jackson Eye — Lake Villa, Illinois, United States
• Cincinnati Eye Institute — Edgewood, Kentucky, United States
• Kentucky Eye Institute — Lexington, Kentucky, United States
• Midwest Vision Research Foundation at Pepose Vision Institute — Chesterfield, Missouri, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Ophthalmology Consultants Ltd. — St Louis, Missouri, United States
• EyeSight Ophthalmic Services — Somersworth, New Hampshire, United States

Full record on ClinicalTrials.gov

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