Post-surgical Ocular InflammationPhase 2NCT04324359
Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
A Phase 2 study testing SURF-201 in people with Post-surgical Ocular Inflammation and Post-surgical Ocular Pain, run by Surface Ophthalmics, Inc. at 10 sites in United States.
Trial summary
SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 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
- Post-surgical Ocular Inflammation, Post-surgical Ocular Pain
- What is being tested?
- SURF-201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Mar 2020to 20 Nov 2020
- 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
- Adult subjects age 18 years or older scheduled for uncomplicated unilateral cataract surgery with posterior chamber intraocular lens (IOL) implantation.
- 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 (surgery eye).
- Subject must agree to maintain their current dosing regimen throughout the study period (from Screening through Day 32) if they are currently using topical cyclosporin-A or Xiidra (lifitegrast 5%).
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- 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).
- Subjects must agree to avoid any medications which are disallowed (as defined by the protocol).
Who cannot join
- Subject has any intraocular inflammation (cells and flare in the anterior chamber) or ocular pain (pain score of >0) in either eye prior to surgery.
- Subject has any extraocular inflammation in the study eye prior to surgery (blepharitis is allowed if only scurf is present without any concurrent conjunctivitis or lid erythema/edema) or ongoing uveitis.
- Subject has a history of diabetic retinopathy and/or previous vitrectomy in the study eye within the last 2 years prior to Screening which, in the investigator's opinion, is clinically significant and could impact the normal outcome of an uncomplicated cataract surgery.
- Subject has a diagnosis of severe dry eye in the study eye.
- Subject has any sign of iritis or scleritis in the study eye.
- Subject has a history of glaucoma surgery in the study eye within the last 2 years prior to Screening.
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- Subject has a history of retinal surgery in the study eye within the last 2 years or plans to undergo retinal surgery in the study eye during the study period (from Screening through Day 32)
- Subject has a history of Fuchs' dystrophy in the study eye.
- Subject has guttata or chalazion in the study eye.
- Subject has undergone radial keratotomy, photorefractive keratotomy, advanced surface ablation, corneal transplant, or LASIK in the study eye within the last 2 years prior to Screening.
- Subject plans to undergo cataract surgery in the non-study (fellow) eye during the study period (from Screening through Day 32).
- Subject plans to undergo additional ocular surgery (including femtosecond laser-assisted cataract surgery, minimally invasive glaucoma surgery, astigmatic keratotomy, limbal relaxing incision surgery, mechanical pupillary expanders, conjunctival incisions, and vitrectomy) in either eye during the study period (from Screening through Day 32).
- Subject has a history of intraocular injections in the study eye within 6 months prior to Screening.
- 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 the study eye. Specifically, active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of the ocular structures (such as fungal keratitis).
- Subject has thinning of the cornea or sclera.
- Subject plans to undergo uncomplicated unilateral cataract surgery with the aid of anterior capsular staining products (e.g., Trypan blue) or with the aid of a femto (femtosecond) laser.
- Subject has undergone anti-neoplastic therapy within the last 2 years prior to Screening or plans to undergo anti-neoplastic therapy during the study period.
- Subject has a history of use of medications to treat benign prostatic hyperplasia that, in the opinion of the investigator, limits adequate dilation of the pupil to safely perform uncomplicated cataract removal and IOL implantation.
- Subject has a history of liver disease within the last 5 years prior to Screening.
- Subject has a history of previous ocular trauma in the study eye that places the study eye at risk of increased post-surgical complications or inflammation.
- Subject has or had a known blood dyscrasia or bone marrow suppression.
- Subject has an active or chronic/recurrent ocular or systemic disease that is not controlled and may have an impact on would healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease).
- Subject is suffering from alcohol and/or drug abuse.
- Subject has a known hypersensitivity or poor tolerance to corticosteroids or any component of the study drug or any of the procedural medications such as anesthetic and/or fluorescein drops, dilating drops, etc.
- Female subjects who are currently pregnant or nursing or are planning to become pregnant during the study or have a positive pregnancy test.
- Subject has previously participated in this study protocol.
- Subject used (within 30 days of initiation of study treatment) or is anticipating concurrent use of an investigational drug or device.
- Subject has a condition or a situation which, in the investigator's opinion, might put the subject at increased risk, confound the study data or interfere significantly with the subject's study participation.
- Subject would be wearing contact lens in either eye during the dosing period of Day -1 to Day 14.
- Subject is taking a medication that the investigator feels might interfere with the study parameters.
- Subject tests positive for the Coronavirus Disease 2019 (COVID-19) virus prior to Visit 1 (Day -14 to Day -2).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Texan Eye Care, PA - Keystone Research, Ltd.
Austin, Texas, 78731
Hernando Eye Institute
Brooksville, Florida, 34613
Inland Eye Specialists
Hemet, California, 92545
Levenson Eye Associates
Jacksonville, Florida, 32204
Eye Care Specialists
Kingston, Pennsylvania, 18704
VRF Eye Specialty Group
Memphis, Tennessee, 38120
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603
R and R Eye Research, LLC
San Antonio, Texas, 78229
East Florida Eye Institute
Stuart, Florida, 34994
About this study
Official title: A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects
SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 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-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.
- Being tested
- SURF-201, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURF-201Drug
Also called 0.2% topical corticosteroid solution
One drop twice daily (BID) in the study eye for 16 days.
PlaceboDrug
Also called Vehicle
One drop twice daily (BID) in the study eye for 16 days.
| Study group | Role | What they receive |
|---|---|---|
| SURF-201 | Experimental | 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) Receives: Drug: SURF-201 |
| Vehicle | Placebo comparator | Topical preservative-free vehicle (Placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows:
ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen
Measured: Day 15
Secondary outcomes (5)
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]).
Measured: Day 1
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]).
Measured: Day 8
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]).
Measured: Day 15
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]).
Measured: Day 22
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent [no pain], 100=maximum [severe pain]).
Measured: Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start3 Mar 2020
- Primary completion3 Nov 2020
- Study completion20 Nov 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-surgical Ocular InflammationStudies 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
- 91 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324359
- Sponsor's protocol ID
- C-201-001
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2020
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hosseini K, Gollamudi S, Reiser H, Walters T, Lindstrom RL. 0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects. Clin Ophthalmol. 2023 Aug 5;17:2219-2230. doi: 10.2147/OPTH.S419857. eCollection 2023.
PubMed 37564159
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects
- ClinicalTrials.gov ID
- NCT04324359
- Acronym / sponsor ID
- C-201-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Surface Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 18 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 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-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different 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
- 2
| Arm | Type | Receives |
|---|---|---|
| SURF-201 | Experimental | Drug: SURF-2010.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) |
| Vehicle | Placebo comparator | Drug: PlaceboTopical preservative-free vehicle (Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult subjects age 18 years or older scheduled for uncomplicated unilateral cataract surgery with posterior chamber intraocular lens (IOL) implantation.
- 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 (surgery eye).
Key exclusion criteria (32 listed)
- Subject has any intraocular inflammation (cells and flare in the anterior chamber) or ocular pain (pain score of >0) in either eye prior to surgery.
- Subject has any extraocular inflammation in the study eye prior to surgery (blepharitis is allowed if only scurf is present without any concurrent conjunctivitis or lid erythema/edema) or ongoing uveitis.
- Subject has a history of diabetic retinopathy and/or previous vitrectomy in the study eye within the last 2 years prior to Screening which, in the investigator's opinion, is clinically significant and could impact the normal outcome of an uncomplicated cataract surgery.
- Subject has a diagnosis of severe dry eye in the study eye.
- Subject has any sign of iritis or scleritis in the study eye.
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 |
|---|---|---|
| SURF-201Also: 0.2% topical corticosteroid solutionOne drop twice daily (BID) in the study eye for 16 days. | Drug | SURF-201 |
| PlaceboAlso: VehicleOne drop twice daily (BID) in the study eye for 16 days. | Drug | Vehicle |
Primary outcome
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
Time frame: Day 15
The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen
5 secondary outcomes
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Time frame: Day 1
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Time frame: Day 8
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Time frame: Day 15
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Time frame: Day 22
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Time frame: Day 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37564159Hosseini K, Gollamudi S, Reiser H, Walters T, Lindstrom RL. 0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects. Clin Ophthalmol. 2023 Aug 5;17:2219-2230. doi: 10.2147/OPTH.S419857. eCollection 2023.
- 0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects.Link provided by the sponsor.
Related trials for Post-surgical Ocular Inflammation
Enrolling by invitationPhase 3
A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Postoperative Ocular Inflammation, Postoperative Ocular Pain
RecruitingPhase 4
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Vitreoretinal Surgery, Ocular Inflammation
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.
10 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 SURF-201 in people with Post-surgical Ocular Inflammation and Post-surgical Ocular Pain, run by Surface Ophthalmics, Inc. at 10 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 9 inclusion and 32 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 18 Oct 2023). 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?
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0 (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324359, which also lists 1 linked publication.
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 15 Jan 2025.