Dry Eye DiseasePhase 2NCT04734210
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 Phase 2 study testing 0.02% Betamethasone Sodium Phosphate and 0.04% Betamethasone Sodium Phosphate in people with Dry Eye Disease, run by Surface Ophthalmics, Inc. at 28 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- 0.02% Betamethasone Sodium Phosphate and 0.04% Betamethasone Sodium Phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 28 sitesUnited States
- Study dates
- 7 Jan 2021to 12 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 0) 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Canyon City EyeCare
Azusa, California, 91702
Chu Vision Institute
Bloomington, Minnesota, 55420
The Eye Associates of Manatee
Bradenton, Florida, 34209
Blue Ocean Clinical Research (The Macula Center)
Clearwater, Florida, 33761
Vision Institute
Colorado Springs, Colorado, 80907
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Connecticut Eye Consultants, PC
Danbury, Connecticut, 06810
Trinity Research Group
Dothan, Alabama, 36301
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
The Eye Center of Northern Colorado
Fort Collins, Colorado, 80528
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Complete Eye Care
Hamel, Minnesota, 55340
Advanced Laser Vision & Surgical Institute
Houston, Texas, 77034
Tauber Eye Center
Kansas City, Missouri, 64111
Kentucky Eye Institute
Lexington, Kentucky, 40517
Total Eye Care, PA
Memphis, Tennessee, 38119
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
West TN EyeCare dba Toyos Clinic
Nashville, Tennessee, 37215
Visionary Eye Institute
Newport Beach, California, 92663
Eye Center of North Florida PA
Panama City, Florida, 32405
North Bay Eye Associates
Petaluma, California, 94954
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603
Martel Eye Medical Group
Rancho Cordova, California, 95670
Coastal Research Associates, LLC
Roswell, Georgia, 30076
R and R Eye Research, LLC
San Antonio, Texas, 78229
Ophthalmology Consultants Ltd.
St Louis, Missouri, 63131
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702
About this study
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
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
- Being tested
- 0.02% Betamethasone Sodium Phosphate, 0.04% Betamethasone Sodium Phosphate, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.02% Betamethasone Sodium PhosphateDrug
topical corticosteroid solution
0.04% Betamethasone Sodium PhosphateDrug
topical corticosteroid solution
PlaceboDrug
topical vehicle solution
| Study group | Role | What they receive |
|---|---|---|
| SURF-200 (0.02% betamethasone sodium phosphate in vehicle) | Experimental | One drop twice daily (BID) in the study eye for 14 days. Receives: Drug: 0.02% Betamethasone Sodium Phosphate |
| SURF-200 (0.04% betamethasone sodium phosphate in vehicle) | Experimental | One drop BID in the study eye for 14 days. Receives: Drug: 0.04% Betamethasone Sodium Phosphate |
| Vehicle | Placebo comparator | One drop BID in the study eye for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 ([1-2] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 ([9-10] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life).
Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Measured: Baseline and Day 8
Secondary outcomes (2)
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 ([1-2] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 ([9-10] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life).
Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
Measured: Baseline and Day 15
Conjunctival Hyperemia Responder Analysis
Conjunctival hyperemia was graded by Investigator using the scale below and clinical grade reference photos:
Grade 0 (none: no hyperemia of the bulbar conjunctiva)
Grade 0.5 (Grade 0 plus dilation of at least a couple of conjunctival blood vessels [CBVs] but less than Grade 1)
Grade 1 (mild: the dilation of a few CBVs)
Grade 1.5 (Grade 1 plus dilation of some CBVs but less than Grade 2)
Grade 2 (moderate: the dilation of several CBVs)
Grade 2.5 (Grade 2 plus dilation of many CBVs but less than Grade 3)
Grade 3 (severe: the abundant and overwhelming dilation of many CBVs)
Participants with a minimum reduction of ≥0.5 point in conjunctival hyperemia grade in the study eye from baseline were defined as responders, and response rates were summarized by treatment group.
Measured: Baseline and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start7 Jan 2021
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surface Ophthalmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamran Hosseini, MD, PhD, Study chair, Surface Ophthalmics, Inc. (formerly Surface Pharmaceuticals, Inc.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734210
- Sponsor's protocol ID
- C-200-001
- Status last verified
- May 2025
- First submitted
- 28 Jan 2021
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04734210
- Acronym / sponsor ID
- C-200-001
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Surface Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SURF-200 (0.02% betamethasone sodium phosphate in vehicle) | Experimental | Drug: 0.02% Betamethasone Sodium PhosphateOne drop twice daily (BID) in the study eye for 14 days. |
| SURF-200 (0.04% betamethasone sodium phosphate in vehicle) | Experimental | Drug: 0.04% Betamethasone Sodium PhosphateOne drop BID in the study eye for 14 days. |
| Vehicle | Placebo comparator | Drug: PlaceboOne drop BID in the study eye for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.02% Betamethasone Sodium Phosphatetopical corticosteroid solution | Drug | SURF-200 (0.02% betamethasone sodium phosphate in vehicle) |
| 0.04% Betamethasone Sodium Phosphatetopical corticosteroid solution | Drug | SURF-200 (0.04% betamethasone sodium phosphate in vehicle) |
| Placebotopical vehicle solution | Drug | Vehicle |
Primary outcome
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
Time frame: Baseline and Day 8
The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 ([1-2] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 ([9-10] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.
2 secondary outcomes
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
Time frame: Baseline and Day 15
Conjunctival Hyperemia Responder Analysis
Time frame: Baseline and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamran Hosseini, MD, PhD study chair
Surface Ophthalmics, Inc. (formerly Surface Pharmaceuticals, Inc.)
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.02% Betamethasone Sodium Phosphate and 0.04% Betamethasone Sodium Phosphate in people with Dry Eye Disease, run by Surface Ophthalmics, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis (time frame: Baseline and Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.