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

A Multicenter, Randomized, Double-Masked, Dose-Ranging Study To Compare The Ocular Safety, Tolerability, And Efficacy Of SURF-200 Ophthalmic Solution (0.02% And 0.04% Betamethasone Sodium Phosphate) To Vehicle In Subjects With A Diagnosis Of Dry Eye Disease And Experiencing An Episodic Flare Up

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: 0.02% Betamethasone Sodium Phosphate; Drug: 0.04% Betamethasone Sodium Phosphate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group
  • California
    • Azusa, California, United States, 91702
      • Canyon City EyeCare
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group, Inc.
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Newport Beach, California, United States, 92663
      • Visionary Eye Institute
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
    • Fort Collins, Colorado, United States, 80528
      • The Eye Center of Northern Colorado
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Connecticut Eye Consultants, PC
  • Florida
    • Bradenton, Florida, United States, 34209
      • The Eye Associates of Manatee
    • Clearwater, Florida, United States, 33761
      • Blue Ocean Clinical Research (The Macula Center)
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Panama City, Florida, United States, 32405
      • Eye Center of North Florida PA
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute
    • Lexington, Kentucky, United States, 40517
      • Kentucky Eye Institute
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute
    • Hamel, Minnesota, United States, 55340
      • Complete Eye Care
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants Ltd.
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Alterman, Modi & Wolter
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37215
      • West TN EyeCare dba Toyos Clinic
  • Texas
    • Houston, Texas, United States, 77034
      • Advanced Laser Vision & Surgical Institute
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SURF-200 (0.02% betamethasone sodium phosphate in vehicle); One drop twice daily (BID) in the study eye for 14 days.	Drug: 0.02% Betamethasone Sodium Phosphate; topical corticosteroid solution
Experimental: SURF-200 (0.04% betamethasone sodium phosphate in vehicle); One drop BID in the study eye for 14 days.	Drug: 0.04% Betamethasone Sodium Phosphate; topical corticosteroid solution
Placebo Comparator: Vehicle; One drop BID in the study eye for 14 days.	Drug: Placebo; topical vehicle solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UNC DEMS Score	A minimum reduction of 1 unit or more in patient-reported dry eye disease symptoms and reduction of impact of symptoms with SURF-200 as compared to vehicle (as measured by the University of North Carolina [UNC] Dry Eye Management Scale [DEMS]).	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UNC DEMS Score	A minimum reduction of 1 unit or more in patient-reported dry eye disease symptoms and reduction of impact of symptoms with SURF-200 as compared to vehicle (as measured by the University of North Carolina [UNC] Dry Eye Management Scale [DEMS]).	Day 15
Conjunctival Hyperemia Assessment	A minimum reduction of 0.5 points or more in conjunctival hyperemia with SURF-200 as compared to vehicle using the Conjunctival Hyperemia Assessment 4 point scale (0-3) in the study eye.	Day 8

Collaborators and Investigators

• Sponsor: Surface Ophthalmics, Inc.
• Investigators: Study Chair: Kamran Hosseini, MD, PhD, Surface Ophthalmics, Inc. (formerly Surface Pharmaceuticals, Inc.)

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
• Other Study ID Numbers: C-200-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No