Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
Condition: Post-surgical Ocular Inflammation; Post-surgical Ocular Pain
MeSH terms: Cataract; Inflammation
Intervention: SURF-201; Placebo
Intervention description: One drop twice daily (BID) in the study eye for 16 days.; One drop twice daily (BID) in the study eye for 16 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult subjects age 18 years or older scheduled for uncomplicated unilateral cataract
             surgery with posterior chamber intraocular lens (IOL) implantation.

          2. Subjects must be able to understand and sign the Informed Consent Form (ICF).

          3. 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.

          4. 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).

          5. Subjects must have an intraocular pressure (IOP) of >8 mmHg and ≤22 mmHg in the study
             eye (surgery eye).

          6. 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%).

          7. Subjects must be willing and able to attend all study visits and follow all
             instructions.

          8. 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).

          9. Subjects must agree to avoid any medications which are disallowed (as defined by the
             protocol).

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. 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.

          4. Subject has a diagnosis of severe dry eye in the study eye.

          5. Subject has any sign of iritis or scleritis in the study eye.

          6. Subject has a history of glaucoma surgery in the study eye within the last 2 years
             prior to Screening.

          7. 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)

          8. Subject has a history of Fuchs' dystrophy in the study eye.

          9. Subject has guttata or chalazion in the study eye.

         10. 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.

         11. Subject plans to undergo cataract surgery in the non-study (fellow) eye during the
             study period (from Screening through Day 32).

         12. 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).

         13. Subject has a history of intraocular injections in the study eye within 6 months prior
             to Screening.

         14. Subject has a history of herpes simplex infection in either eye.

         15. 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).

         16. Subject has thinning of the cornea or sclera.

         17. 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.

         18. 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.

         19. 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.

         20. Subject has a history of liver disease within the last 5 years prior to Screening.

         21. 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.

         22. Subject has or had a known blood dyscrasia or bone marrow suppression.

         23. 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).

         24. Subject is suffering from alcohol and/or drug abuse.

         25. 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.

         26. Female subjects who are currently pregnant or nursing or are planning to become
             pregnant during the study or have a positive pregnancy test.

         27. Subject has previously participated in this study protocol.

         28. Subject used (within 30 days of initiation of study treatment) or is anticipating
             concurrent use of an investigational drug or device.

         29. 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.

         30. Subject would be wearing contact lens in either eye during the dosing period of Day -1
             to Day 14.

         31. Subject is taking a medication that the investigator feels might interfere with the
             study parameters.

         32. Subject tests positive for the Coronavirus Disease 2019 (COVID-19) virus prior to
             Visit 1 (Day -14 to Day -2).