Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
Condition: Intraocular Lens Replacement; Intraoperative Floppy Iris Syndrome
MeSH terms: Syndrome
Intervention: Part 1 OMS302; Part 2 OMS302; Part 2 Placebo
Intervention description: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.; OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.; Placebo drug product is a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative
      Floppy Iris Syndrome in patients at risk.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Competent to provide informed consent.

          2. Voluntarily provide informed consent and HIPAA Authorization in accordance with local
             regulations and governing IEC/IRB requirements prior to any procedures or evaluations
             performed specifically for the sole purpose of the study.

          3. Indicate they understand and are able, willing, and likely to fully comply with study
             procedures and restrictions.

          4. Are male and 18 years of age or older at the time of surgery.

          5. Are to undergo unilateral primary ILR, under topical anesthesia, with insertion of an
             intraocular lens.

          6. Have a best-corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.

          7. Have an intraocular pressure (IOP) between 5 mm Hg and 22 mm Hg, inclusive, in the
             study eye.

          8. Is currently and has been taking tamsulosin (Flomax®) for at least six months.

        Exclusion Criteria:

          1. Hypersensitivity to phenylephrine, ketoprofen, bromfenac, or other NSAIDs, including
             aspirin.

          2. Hypersensitivity to tetracaine, lidocaine, ophthalmic viscoelastic devices (such as
             hydroxypropylmethylcellulose or hyaluronic acid or latex..

          3. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal,
             hematological, endocrine, neurological, psychiatric, respiratory or other medical
             condition that could increase the risk to the subject as determined by the
             Investigator.

          4. Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis,
             fibromyalgia).

          5. Presence of systolic blood pressure of greater than 170 mmHg or less than 90 mmHg, or
             diastolic blood pressure of greater than110 mmHg or less than 40 mmHg at the screening
             visit.

          6. Use of phenylephrine in the study eye (other than for the screening ophthalmological
             examination) within seven days prior to the day of surgery.

          7. Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery.

          8. Use of pilocarpine in the study eye within seven days prior to the day of surgery.

          9. Presence of narrow-angle glaucoma or unstable glaucoma.

         10. Glaucoma being treated with prostaglandins or prostaglandin analogues such as
             Xalatan®, Lumigan®, Travatan®, and Rescula®, or Alphagan® (brimonidine tartrate) in
             either eye during the seven days prior to screening and through Day 7 postoperatively.

         11. Presence of pseudo-capsular exfoliation in either eye.

         12. History of iritis, or of any ocular trauma with iris damage in the study eye.

         13. Presence of uncontrolled chronic ocular diseases in either eye that could affect pupil
             dilation.

         14. Presence of active corneal pathology in either eye (except superficial punctate
             keratopathy in the non-study eye).

         15. Presence of extraocular/intraocular inflammation in either eye.

         16. Presence of active bacterial and/or viral infection in either eye.

         17. Participating in any investigational drug or device trial within the 30 days prior to
             the day of surgery.

         18. History of intraocular non-laser surgery in the study eye within the three months
             prior to the day of surgery, or intraocular laser surgery in the study eye within 30
             days prior to the day of surgery.

         19. Presence of any condition that the Investigator believes would put the subject at risk
             or confound the interpretation of the study data.

         20. Investigators, employees of the investigative site, and their immediate families.
             Immediate family is defined as the Investigator's or employees' current spouse,
             parent, natural or legally adopted child (including a stepchild living in the
             Investigator's household), grandparent, or grandchild.

         21. Prior participation in a clinical study of OMS302.