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

NCT04734197 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C-100-001
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 40

Brief 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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (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.

  Baseline and Day 84

Secondary Outcomes (2)

• Tear Break Up Time (TBUT), Study Eye

  Baseline and Day 84

• Schirmer Tear Test Score, Study Eye

  Baseline and Day 84

Study Arms (7)

SURF-100 (a combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)

EXPERIMENTAL

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days

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

Mycophenolic Acid 0.1%

EXPERIMENTAL

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.

Drug: Mycophenolic Acid 0.1%

Mycophenolic Acid 0.3%

EXPERIMENTAL

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.

Drug: Mycophenolic Acid 0.3%

Betamethasone Sodium Phosphate 0.01%

EXPERIMENTAL

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.

Drug: Betamethasone Sodium Phosphate 0.01%

Vehicle

PLACEBO COMPARATOR

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days.

Drug: Placebo Comparator: Vehicle

Cyclosporine 0.05% Ophthalmic Emulsion

ACTIVE COMPARATOR

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days

Drug: Cyclosporine 0.05% Ophthalmic Emulsion

Lifitegrast 5% Ophthalmic Solution

ACTIVE COMPARATOR

One drop in the study eye (and fellow eye, if applicable) twice daily for 84 days

Drug: Lifitegrast 5% Ophthalmic Solution

Interventions

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

SURF-100 (a combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)

Mycophenolic Acid 0.1% DRUG

topical immunosuppressant

Mycophenolic Acid 0.1%

Mycophenolic Acid 0.3% DRUG

topical immunosuppressant

Mycophenolic Acid 0.3%

Betamethasone Sodium Phosphate 0.01% DRUG

topical corticosteroid solution

Betamethasone Sodium Phosphate 0.01%

Placebo Comparator: Vehicle DRUG

topical vehicle solution

Vehicle

Cyclosporine 0.05% Ophthalmic Emulsion DRUG

topical ophthalmic emulsion

Also known as: Restasis 0.05% ophthalmic emulsion

Cyclosporine 0.05% Ophthalmic Emulsion

Lifitegrast 5% Ophthalmic Solution DRUG

topical ophthalmic solution

Also known as: Xiidra 5% Ophthalmic Solution

Lifitegrast 5% Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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).

Sponsors & Collaborators

• Surface Ophthalmics, Inc.: lead

Study Sites (40)

Cornea and Cataract Consultants of Arizona PC

Phoenix, Arizona, 85032, United States

Location

Canyon City EyeCare

Azusa, California, 91702, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

North Valley Eye Medical Group Inc.

Mission Hills, California, 91345, United States

Location

LoBue Laser and Eye Medical Center

Murrieta, California, 92562, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Sacramento Eye Consultants, A Medical Corporation

Sacramento, California, 95815, United States

Location

The Eye Center of Northern Colorado

Fort Collins, Colorado, 80528, United States

Location

Connecticut Eye Consultants, PC

Danbury, Connecticut, 06810, United States

Location

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, 33426, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34613, United States

Location

Bowden Eye and Associates

Jacksonville, Florida, 32256, United States

Location

Eye Center of North Florida PA

Panama City, Florida, 32405, United States

Location

International Research Center

Tampa, Florida, 33603, United States

Location

Blue Ocean Clinical Research at The Macula Center

The Villages, Florida, 32162, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Jackson Eye

Lake Villa, Illinois, 60046, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Midwest Vision Research Foundation at Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Ophthalmology Consultants Ltd.

St Louis, Missouri, 63131, United States

Location

EyeSight Ophthalmic Services

Somersworth, New Hampshire, 03878, United States

Location

Alterman, Modi & Wolter

Poughkeepsie, New York, 12603, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27401, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

West TN EyeCare dba Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Texan Eye Care, PA - Keystone Research, Ltd

Austin, Texas, 78731, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Advanced Laser Vision & Surgical Institute

Houston, Texas, 77034, United States

Location

Eye Clinics of South Texas, PA

San Antonio, Texas, 78209, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Mycophenolic Acid; betamethasone sodium phosphate; Cyclosporine; Cyclosporins; lifitegrast; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: Surface Ophthalmics, Inc.

cbaenziger@surfaceophthalmics.com

(925) 494-3660

Study Officials

• Kamran Hosseini, MD, PhD

  Surface Ophthalmics, Inc. (formerly Surface Pharmaceutials, Inc.)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 2, 2021
• Study Start: January 11, 2021
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: May 11, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-04

Locations

US (40)