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

Sponsor

Surface Pharmaceuticals, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04734210

Collaborator

(none)

120

Enrollment

Locations

Arms

20.8

Anticipated Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: 0.02% Betamethasone Sodium Phosphate Drug: 0.04% Betamethasone Sodium Phosphate Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 7, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

UNC DEMS Score [Day 8]
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]).

Secondary Outcome Measures

UNC DEMS Score [Day 15]
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]).
Conjunctival Hyperemia Assessment [Day 8]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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.

Exclusion Criteria:

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).
Subject has a history of glaucoma.
Subject has a history of herpes simplex infection in either eye.
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).
Subject has thinning of the cornea or sclera in the study eye.
Subject has active anterior blepharitis in the study eye.
Subject has a history of uveitis in the study eye.
Subject is suffering from alcohol and/or drug abuse.
Subject has tested positive for the COVID-19 virus within 30 days prior to Screening Visit 1 (Day -14 to Day 0).
Subject has previously received treatment in this study protocol.
Subject is taking a medication, that in the opinion of the investigator, might interfere with the study parameters.

Contacts and Locations

Locations

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