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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734210
• Other study ID #: C-200-001
• Status: Completed
• Phase: Phase 2
• Start date: January 7, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: October 2023
• Source: Surface Ophthalmics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 0.02% Betamethasone Sodium Phosphate
topical corticosteroid solution
• 0.04% Betamethasone Sodium Phosphate
topical corticosteroid solution
• Placebo
topical vehicle solution

Locations

Country	Name	City	State
United States	Canyon City EyeCare	Azusa	California
United States	Chu Vision Institute	Bloomington	Minnesota
United States	The Eye Associates of Manatee	Bradenton	Florida
United States	Blue Ocean Clinical Research (The Macula Center)	Clearwater	Florida
United States	Vision Institute	Colorado Springs	Colorado
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Connecticut Eye Consultants, PC	Danbury	Connecticut
United States	Trinity Research Group	Dothan	Alabama
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	The Eye Center of Northern Colorado	Fort Collins	Colorado
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Complete Eye Care	Hamel	Minnesota
United States	Advanced Laser Vision & Surgical Institute	Houston	Texas
United States	Tauber Eye Center	Kansas City	Missouri
United States	Kentucky Eye Institute	Lexington	Kentucky
United States	Total Eye Care, PA	Memphis	Tennessee
United States	North Valley Eye Medical Group, Inc.	Mission Hills	California
United States	LoBue Laser and Eye Medical Center	Murrieta	California
United States	West TN EyeCare dba Toyos Clinic	Nashville	Tennessee
United States	Visionary Eye Institute	Newport Beach	California
United States	Eye Center of North Florida PA	Panama City	Florida
United States	North Bay Eye Associates	Petaluma	California
United States	Alterman, Modi & Wolter	Poughkeepsie	New York
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Ophthalmology Consultants Ltd.	Saint Louis	Missouri
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Bucci Laser Vision	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Surface Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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