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Dry Eye DiseasePhase 2NCT04734197

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

A Phase 2 study testing SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1% and Mycophenolic Acid 0.3% in people with Dry Eye Disease, run by Surface Ophthalmics, Inc. at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1% and Mycophenolic Acid 0.3%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
349 participants
Where
40 sitesUnited States
Study dates
11 Jan 2021to 25 Mar 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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).
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  • 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).
  • Diuretics: Within 28 days prior to Visit 1 (Day -14 to Day -1).
  • Punctal occlusion:
  • Punctal cauterization: Randomization may not occur until 4 weeks following the procedure.
  • Permanent/semi-permanent punctal plugs (this includes 180-day punctal plugs): Randomization may not occur until 4 weeks following the procedure. If a punctal plug falls out during the study, it should be reinserted.
  • Temporary collagen punctal plugs: Not permitted. If subject has a history of use of temporary punctal plugs, randomization may not occur until 4 weeks since last insertion and puncta are plug-free, as determined by the investigator.
  • Any significant chronic illness that, in the opinion of the investigator, could interfere with the study parameters, including, but not limited to, severe cardiopulmonary disease, poorly controlled hypertension, and/or poorly controlled diabetes.
  • Use of any investigational product or device within 30 days prior to Visit 1 (Day -14 to Day 0) or during the study period.
  • History of LASIK or similar type of corneal refractive surgery within 12 months prior to Visit 1 (Day -14 to Day 0), and/or any other ocular surgical procedure within 12 months prior to Visit 1 (Day -14 to Day 0); or any scheduled ocular surgical procedure during the study period.
  • Use of any laser procedure for the eyes in the 30 days prior to Visit 1 (Day -14 to Day 0).
  • Known history of alcohol and/or drug abuse within the past 12 months that in the opinion of the principal investigator, may interfere with study compliance, outcome measures including safety parameters, and/or the general medical condition of the subject.
  • Subjects with dry eye secondary to scarring (such as that seen with irradiation, alkali burns, Stevens Johnson syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (as with vitamin A deficiency) are not eligible for the study. Subjects with incidental scars secondary to refractory surgery (i.e., LASIK surgery) that, in the opinion of the principal investigator, would not interfere with study compliance and/or outcome measures, are not excluded from the study.
  • Subjects who test positive for the COVID-19 virus within 30 days prior to Visit 1 (Day -14 to Day 0).

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Texan Eye Care, PA - Keystone Research, Ltd

    Austin, Texas, 78731

  • Canyon City EyeCare

    Azusa, California, 91702

  • Florida Eye Microsurgical Institute, Inc.

    Boynton Beach, Florida, 33426

  • Hernando Eye Institute

    Brooksville, Florida, 34613

  • Midwest Vision Research Foundation at Pepose Vision Institute

    Chesterfield, Missouri, 63017

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania, 16066

  • Connecticut Eye Consultants, PC

    Danbury, Connecticut, 06810

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017

  • The Eye Center of Northern Colorado

    Fort Collins, Colorado, 80528

  • Physicians Protocol

    Greensboro, North Carolina, 27401

  • Inland Eye Specialists

    Hemet, California, 92545

  • Houston Eye Associates

    Houston, Texas, 77025

  • Advanced Laser Vision & Surgical Institute

    Houston, Texas, 77034

  • Bowden Eye and Associates

    Jacksonville, Florida, 32256

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • Jackson Eye

    Lake Villa, Illinois, 60046

  • Tanner Clinic

    Layton, Utah, 84041

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517

  • Total Eye Care, PA

    Memphis, Tennessee, 38119

  • VRF Eye Specialty Group

    Memphis, Tennessee, 38120

  • North Valley Eye Medical Group Inc.

    Mission Hills, California, 91345

  • LoBue Laser and Eye Medical Center

    Murrieta, California, 92562

  • West TN EyeCare dba Toyos Clinic

    Nashville, Tennessee, 37215

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Eye Center of North Florida PA

    Panama City, Florida, 32405

  • Cornea and Cataract Consultants of Arizona PC

    Phoenix, Arizona, 85032

  • Alterman, Modi & Wolter

    Poughkeepsie, New York, 12603

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Rochester Ophthalmological Group, PC

    Rochester, New York, 14618

  • Coastal Research Associates, LLC

    Roswell, Georgia, 30076

  • Sacramento Eye Consultants, A Medical Corporation

    Sacramento, California, 95815

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

  • Eye Clinics of South Texas, PA

    San Antonio, Texas, 78209

  • R and R Eye Research, LLC

    San Antonio, Texas, 78229

  • EyeSight Ophthalmic Services

    Somersworth, New Hampshire, 03878

  • Tekwani Vision Center

    St Louis, Missouri, 63128

  • Ophthalmology Consultants Ltd.

    St Louis, Missouri, 63131

  • International Research Center

    Tampa, Florida, 33603

  • Blue Ocean Clinical Research at The Macula Center

    The Villages, Florida, 32162

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Masked Study To Evaluate The Safety, Tolerability, And Efficacy Of SURF-100 Ophthalmic Solution (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination) In Subjects With Dry Eye Disease

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.

Conditions
Dry Eye Disease
Being tested
SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1%, Mycophenolic Acid 0.3%, Betamethasone Sodium Phosphate 0.01%, Placebo Comparator: Vehicle
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)Drug

    combination of a topical immunosuppressant and a topical corticosteroid solution

  • Mycophenolic Acid 0.1%Drug

    topical immunosuppressant

  • Mycophenolic Acid 0.3%Drug

    topical immunosuppressant

  • Betamethasone Sodium Phosphate 0.01%Drug

    topical corticosteroid solution

  • Placebo Comparator: VehicleDrug

    topical vehicle solution

  • Cyclosporine 0.05% Ophthalmic EmulsionDrug

    Also called Restasis 0.05% ophthalmic emulsion

    topical ophthalmic emulsion

  • Lifitegrast 5% Ophthalmic SolutionDrug

    Also called Xiidra 5% Ophthalmic Solution

    topical ophthalmic solution

Study groups in NCT04734197
Study groupRoleWhat they receive
SURF-100 (a combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)ExperimentalOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Receives: Drug: SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
Mycophenolic Acid 0.1%ExperimentalOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Receives: Drug: Mycophenolic Acid 0.1%
Mycophenolic Acid 0.3%ExperimentalOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Receives: Drug: Mycophenolic Acid 0.3%
Betamethasone Sodium Phosphate 0.01%ExperimentalOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Receives: Drug: Betamethasone Sodium Phosphate 0.01%
VehiclePlacebo comparatorOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.
Receives: Drug: Placebo Comparator: Vehicle
Cyclosporine 0.05% Ophthalmic EmulsionActive comparatorOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Receives: Drug: Cyclosporine 0.05% Ophthalmic Emulsion
Lifitegrast 5% Ophthalmic SolutionActive comparatorOne drop in the study eye (and fellow eye, if applicable) twice daily for 84 days
Receives: Drug: Lifitegrast 5% Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis

    The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 ([1-2] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 ([9-10] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life).

    Participants with a 10% or higher reduction in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.

    Measured: Baseline and Day 84

Secondary outcomes (2)

  1. Tear Break Up Time (TBUT), Study Eye

    The absolute change from baseline in TBUT in the study eye at Day 84.

    Measured: Baseline and Day 84

  2. Schirmer Tear Test Score, Study Eye

    The absolute change from baseline in Schirmer tear score in the study eye at Day 84.

    Measured: Baseline and Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start11 Jan 2021
  3. Primary completion25 Mar 2022
  4. Study completion25 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04734197
Sponsor's protocol ID
C-100-001
Status last verified
Apr 2025
First submitted
28 Jan 2021
Last updated
11 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1% and Mycophenolic Acid 0.3% in people with Dry Eye Disease, run by Surface Ophthalmics, Inc. at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis (time frame: Baseline and Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04734197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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