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

NCT ID: NCT04734210

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2022-10-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

0.02% Betamethasone Sodium Phosphate

Intervention Type: DRUG

topical corticosteroid solution

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

One drop BID in the study eye for 14 days.

Group Type: EXPERIMENTAL

0.04% Betamethasone Sodium Phosphate

Intervention Type: DRUG

topical corticosteroid solution

Vehicle

One drop BID in the study eye for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

topical vehicle solution

Interventions

0.02% Betamethasone Sodium Phosphate

topical corticosteroid solution

Intervention Type: DRUG

0.04% Betamethasone Sodium Phosphate

topical corticosteroid solution

Intervention Type: DRUG

Placebo

topical vehicle solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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:

1. UNC DEMS score of greater than or equal to 5 but less than or equal to 9

2. Conjunctival hyperemia score of greater than or equal to 2 in the study eye when using the conjunctival hyperemia reference photos

3. Schirmer's Tear Test score (with anesthesia) greater than 1 mm but less than or equal to12 mm in the study eye

2. Subjects must be able to understand and sign the Informed Consent Form (ICF).

3. 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.

4. 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).

5. Subjects must have an intraocular pressure (IOP) of >8 mmHg and ≤22 mmHg in the study eye.

6. 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.

7. 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.

8. Subjects must be willing and able to attend all study visits and follow all instructions.

9. 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).

10. Have a history of use or desire to use an eye drop for dry eye symptoms for longer than the past 6 months.

Exclusion Criteria

1. 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.

2. 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).

3. 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.

4. 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.

5. Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.

6. History of high IOP response to steroids.

7. Participated in an ophthalmic investigational product clinical trial within 30 days of Screening Visit 1 (Day -14 to Day 0).

8. Active collagen vascular disorder or autoimmune disease.

9. 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.

10. Known hypersensitivity to any component of the study drug or procedural medications.

11. Known hypersensitivity to steroids.

12. Any active corneal epithelial/stromal pathology noted in the study eye at Screening Visit 1 (Day -14 to Day 0).

13. Any history of corneal surgery in the study eye (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK).

14. Any ocular surgery in the study eye within the past year.

15. 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).

16. Subject has a history of glaucoma.

17. Subject has a history of herpes simplex infection in either eye.

18. Subject has active corneal, conjunctival or canalicular pathology (including ocular infection [bacterial, viral or fungal]) in either eye. Specifically, active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and mycobacterial infection of either eye and fungal diseases of the ocular structures (such as fungal keratitis).

19. Subject has thinning of the cornea or sclera in the study eye.

20. Subject has active anterior blepharitis in the study eye.

21. Subject has a history of uveitis in the study eye.

22. Subject is suffering from alcohol and/or drug abuse.

23. Subject has tested positive for the COVID-19 virus within 30 days prior to Screening Visit 1 (Day -14 to Day 0).

24. Subject has previously received treatment in this study protocol.

25. Subject is taking a medication, that in the opinion of the investigator, might interfere with the study parameters.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surface Ophthalmics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kamran Hosseini, MD, PhD

Role: STUDY_CHAIR

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

Locations

Trinity Research Group

Dothan, Alabama, United States

Canyon City EyeCare

Azusa, California, United States

North Valley Eye Medical Group, Inc.

Mission Hills, California, United States

LoBue Laser and Eye Medical Center

Murrieta, California, United States

Visionary Eye Institute

Newport Beach, California, United States

North Bay Eye Associates

Petaluma, California, United States

Martel Eye Medical Group

Rancho Cordova, California, United States

Vision Institute

Colorado Springs, Colorado, United States

The Eye Center of Northern Colorado

Fort Collins, Colorado, United States

Connecticut Eye Consultants, PC

Danbury, Connecticut, United States

The Eye Associates of Manatee

Bradenton, Florida, United States

Blue Ocean Clinical Research (The Macula Center)

Clearwater, Florida, United States

Eye Associates of Fort Myers

Fort Myers, Florida, United States

Eye Center of North Florida PA

Panama City, Florida, United States

Coastal Research Associates, LLC

Roswell, Georgia, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Kentucky Eye Institute

Lexington, Kentucky, United States

Chu Vision Institute

Bloomington, Minnesota, United States

Complete Eye Care

Hamel, Minnesota, United States

Tauber Eye Center

Kansas City, Missouri, United States

Ophthalmology Consultants Ltd.

St Louis, Missouri, United States

Alterman, Modi & Wolter

Poughkeepsie, New York, United States

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, United States

Total Eye Care, PA

Memphis, Tennessee, United States

West TN EyeCare dba Toyos Clinic

Nashville, Tennessee, United States

Advanced Laser Vision & Surgical Institute

Houston, Texas, United States

R and R Eye Research, LLC

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C-200-001

Identifier Type: -

Identifier Source: org_study_id