Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease

NCT04734210 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C-200-001
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 28

Brief Summary

SURF-200 is being studied in people experiencing an episodic flare-up of their dry eye disease. SURF-200 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-200 works and what side effects there are, and to compare it with vehicle (placebo). The study will involve about 120 study participants at multiple 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 minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.

  Baseline and Day 8

Secondary Outcomes (2)

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

  Baseline and Day 15

• Conjunctival Hyperemia Responder Analysis

  Baseline and Day 8

Study Arms (3)

SURF-200 (0.02% betamethasone sodium phosphate in vehicle)

EXPERIMENTAL

One drop twice daily (BID) in the study eye for 14 days.

Drug: 0.02% Betamethasone Sodium Phosphate

SURF-200 (0.04% betamethasone sodium phosphate in vehicle)

EXPERIMENTAL

One drop BID in the study eye for 14 days.

Drug: 0.04% Betamethasone Sodium Phosphate

Vehicle

PLACEBO COMPARATOR

One drop BID in the study eye for 14 days.

Drug: Placebo

Interventions

0.02% Betamethasone Sodium Phosphate DRUG

topical corticosteroid solution

SURF-200 (0.02% betamethasone sodium phosphate in vehicle)

0.04% Betamethasone Sodium Phosphate DRUG

topical corticosteroid solution

SURF-200 (0.04% betamethasone sodium phosphate in vehicle)

Placebo DRUG

topical vehicle solution

Vehicle

Eligibility Criteria

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

You may qualify if:

• Subjects 18 years of age and older who have a diagnosis of dry eye disease and experiencing an episodic flare up. Criteria for the diagnosis must include the following:
• UNC DEMS score of greater than or equal to 5 but less than or equal to 9
• Conjunctival hyperemia score of greater than or equal to 2 in the study eye when using the conjunctival hyperemia reference photos
• Schirmer's Tear Test score (with anesthesia) greater than 1 mm but less than or equal to12 mm in the study eye
• Subjects must be able to understand and sign the Informed Consent Form (ICF).
• Female subjects of childbearing potential must agree to and submit a negative urine pregnancy test before any study-specific procedures are performed. The subjects must be using and continue to use a suitable method of contraception for the duration of the study: spermicide with barrier, oral contraceptive, transdermal contraceptive, injectable or implantable contraceptive, intrauterine device (IUD), abstinence or surgical sterilization of a partner. If a subject is not of childbearing potential (e.g., has been postmenopausal for at least 12 months or is premenarchal, or has undergone a hysterectomy, bilateral oophorectomy or a bilateral tubal ligation), a urine pregnancy test and use of a suitable method of contraception for the duration of the study will not be required.
• Subjects must have a best-corrected visual acuity (BCVA) of at least +1.0 log of the minimum angle of resolution (logMAR) (Snellen equivalent of 20/200) in the non-study eye (fellow eye).
• Subjects must have an intraocular pressure (IOP) of \>8 mmHg and ≤22 mmHg in the study eye.
• Subjects who are on Restasis, Xiidra or other cyclosporine ophthalmic eye drops must be on a stable dose for at least 4 months prior to Screening Visit 1 (Day -14 to Day 0) and remain compliant with the use of these medications throughout the duration of this study.
• Subjects who are on artificial tears, oral antihistamines, beta blockers and diuretics must be on a stable dose for at least 1 month prior to Screening Visit 1 (Day -14 to Day 0) and remain compliant with the use of these medications throughout the duration of this study.
• Subjects must be willing and able to attend all study visits and follow all instructions.
• Subjects must be able to self-instill the study drug (if unable, a caregiver must be available to instill all doses of the study drug).
• Have a history of use or desire to use an eye drop for dry eye symptoms for longer than the past 6 months.

You may not qualify if:

• Females who are pregnant or nursing or planning to become pregnant during the study. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study.
• Use of contact lenses in either eye during the study. Contact lens wear must have been discontinued at least 2 weeks prior to Baseline/Randomization Visit 2 (Day 1).
• Use of corticosteroids or nonsteroidal anti-inflammatory agents (NSAID) (except oral doses of aspirin at 81 mg/day or lower) within 2 weeks of the initiation of study drug at Baseline/Randomization Visit 2 (Day 1) and for the remainder of the study.
• Inhaled, ingested, sublingual, transdermal or topical products containing marijuana, tetrahydrocannabinol (THC) or cannabidiol (CBD) within 7 days of the first dose of study drug at Baseline/Randomization Visit 2 (Day 1) and for the remainder of the study.
• Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
• History of high IOP response to steroids.
• Participated in an ophthalmic investigational product clinical trial within 30 days of Screening Visit 1 (Day -14 to Day 0).
• Active collagen vascular disorder or autoimmune disease.
• A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
• Known hypersensitivity to any component of the study drug or procedural medications.
• Known hypersensitivity to steroids.
• Any active corneal epithelial/stromal pathology noted in the study eye at Screening Visit 1 (Day -14 to Day 0).
• Any history of corneal surgery in the study eye (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK).
• Any ocular surgery in the study eye within the past year.
• Subject has punctal occlusion with any modality or a change in punctal plug status in either eye within the 3 months prior to Screening Visit 1 (Day -14 to Day 0).

Sponsors & Collaborators

• Surface Ophthalmics, Inc.: lead

Study Sites (28)

Trinity Research Group

Dothan, Alabama, 36301, United States

Location

Canyon City EyeCare

Azusa, California, 91702, 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

Visionary Eye Institute

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, 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

The Eye Associates of Manatee

Bradenton, Florida, 34209, United States

Location

Blue Ocean Clinical Research (The Macula Center)

Clearwater, Florida, 33761, United States

Location

Eye Associates of Fort Myers

Fort Myers, Florida, 33901, United States

Location

Eye Center of North Florida PA

Panama City, Florida, 32405, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Complete Eye Care

Hamel, Minnesota, 55340, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Ophthalmology Consultants Ltd.

St Louis, Missouri, 63131, United States

Location

Alterman, Modi & Wolter

Poughkeepsie, New York, 12603, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

West TN EyeCare dba Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Advanced Laser Vision & Surgical Institute

Houston, Texas, 77034, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

betamethasone sodium phosphate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

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 Pharmaceuticals, 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 7, 2021
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Locations

US (28)