Clinical trial NCT04734210: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Surface Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
timeFrame: Baseline and Day 8
Secondary outcomes:
measure: University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
timeFrame: Baseline and Day 15
measure: Conjunctival Hyperemia Responder Analysis
timeFrame: Baseline and Day 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Azusa
country: United States
facility: Canyon City EyeCare
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
state: California
city: Newport Beach
country: United States
facility: Visionary Eye Institute
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Fort Collins
country: United States
facility: The Eye Center of Northern Colorado
state: Colorado
city: Danbury
country: United States
facility: Connecticut Eye Consultants, PC
state: Connecticut
city: Bradenton
country: United States
facility: The Eye Associates of Manatee
state: Florida
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research (The Macula Center)
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Panama City
country: United States
facility: Eye Center of North Florida PA
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Lexington
country: United States
facility: Kentucky Eye Institute
state: Kentucky
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Hamel
country: United States
facility: Complete Eye Care
state: Minnesota
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultants Ltd.
state: Missouri
city: Poughkeepsie
country: United States
facility: Alterman, Modi & Wolter
state: New York
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: West TN EyeCare dba Toyos Clinic
state: Tennessee
city: Houston
country: United States
facility: Advanced Laser Vision & Surgical Institute
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
Study officials:
affiliation: Surface Ophthalmics, Inc. (formerly Surface Pharmaceuticals, Inc.)
name: Kamran Hosseini, MD, PhD
role: STUDY_CHAIR
References: