Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Su… (NCT04324359) | Clinical Trial Compass
CompletedPhase 2
Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
United States91 participantsStarted 2020-03-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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%).
What they're measuring
1
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
✓. 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).
Exclusion criteria
✕. 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.