Phase 2
N=349
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
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT04734197 ↗Enrolled (actual)
349
Serious AEs
0.9%
Results posted
Mar 2025
Primary outcome: Primary: University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis — 65.4; 90.0; 66.0; 71.4 percentage of responders — p=0.0040
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate) (Drug); Mycophenolic Acid 0.1% (Drug); Mycophenolic Acid 0.3% (Drug); Betamethasone Sodium Phosphate 0.01% (Drug); Placebo Comparator: Vehicle (Drug); Cyclosporine 0.05% Ophthalmic Emulsion (Drug); Lifitegrast 5% Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Surface Ophthalmics, Inc.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis |
65.4; 90.0; 66.0; 71.4; 80.9; 72.3 | 0.0040 sig |
| SECONDARY Tear Break Up Time (TBUT), Study Eye |
1.70; 1.84; 1.41; 2.56; 1.12; 2.40 | 0.3111 |
| SECONDARY Schirmer Tear Test Score, Study Eye |
3.20; 2.94; 4.46; 1.66; 3.98; 2.25 | 0.2027 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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, nu
Data sourced from ClinicalTrials.gov (NCT04734197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.