Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects

NCT04324359 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C-201-001
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Post-surgical Ocular Inflammation; Post-surgical Ocular Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Day 15

Secondary Outcomes (5)

• Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0

  Day 1

• Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0

  Day 8

• Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0

  Day 15

• Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0

  Day 22

• Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0

  Day 32

Study Arms (2)

SURF-201

EXPERIMENTAL

0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate)

Drug: SURF-201

Vehicle

PLACEBO COMPARATOR

Topical preservative-free vehicle (Placebo)

Drug: Placebo

Interventions

SURF-201 DRUG

One drop twice daily (BID) in the study eye for 16 days.

Also known as: 0.2% topical corticosteroid solution

SURF-201

Placebo DRUG

One drop twice daily (BID) in the study eye for 16 days.

Also known as: Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Surface Ophthalmics, Inc.: lead

Study Sites (10)

Inland Eye Specialists

Hemet, California, 92545, United States

Location

LoBue Laser and Eye Medical Center

Murrieta, California, 92562, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34613, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Alterman, Modi & Wolter

Poughkeepsie, New York, 12603, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Texan Eye Care, PA - Keystone Research, Ltd.

Austin, Texas, 78731, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 37564159 BACKGROUND

Related Links

• 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.

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: Surface Ophthalmics Inc.

cbaenziger@surfaceophthalmics.com

(925) 494-3660

Study Officials

• Kamran Hosseini, MD, PhD

  Surface Ophthalmics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: March 3, 2020
• Primary Completion: November 3, 2020
• Study Completion: November 20, 2020
• Last Updated: January 15, 2025
• Results First Posted: October 18, 2023

Record last verified: 2025-01

Locations

US (10)