Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

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

Detailed Description
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OMS302 is a mydriatic/anti-inflammatory combination investigational drug product being developed for use during intraoperative lens replacement (ILR). This study evaluates the effect of OMS302 on the signs of Floppy Iris Syndrome in subjects with a history of tamsulosin exposure who are undergoing ILR.

Official Title
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A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter in Subjects at High Risk of Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

Conditions
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Intraocular Lens Replacement, Intraoperative Floppy Iris Syndrome

Intervention / Treatment
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* Drug: Part 1 OMS302
* Drug: Part 2 OMS302
* Drug: Part 2 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Competent to provide informed consent. 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. Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions. Are male and 18 years of age or older at the time of surgery. Are to undergo unilateral primary ILR, under topical anesthesia, with insertion of an intraocular lens. Have a best-corrected visual acuity (BCVA) of 20/400 or better in the non-study eye. Have an intraocular pressure (IOP) between 5 mm Hg and 22 mm Hg, inclusive, in the study eye. Is currently and has been taking tamsulosin (Flomax®) for at least six months. Exclusion Criteria: Hypersensitivity to phenylephrine, ketoprofen, bromfenac, or other NSAIDs, including aspirin. Hypersensitivity to tetracaine, lidocaine, ophthalmic viscoelastic devices (such as hydroxypropylmethylcellulose or hyaluronic acid or latex.. 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. Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis, fibromyalgia). 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. Use of phenylephrine in the study eye (other than for the screening ophthalmological examination) within seven days prior to the day of surgery. Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery. Use of pilocarpine in the study eye within seven days prior to the day of surgery. Presence of narrow-angle glaucoma or unstable glaucoma. 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. Presence of pseudo-capsular exfoliation in either eye. History of iritis, or of any ocular trauma with iris damage in the study eye. Presence of uncontrolled chronic ocular diseases in either eye that could affect pupil dilation. Presence of active corneal pathology in either eye (except superficial punctate keratopathy in the non-study eye). Presence of extraocular/intraocular inflammation in either eye. Presence of active bacterial and/or viral infection in either eye. Participating in any investigational drug or device trial within the 30 days prior to the day of surgery. 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. Presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of the study data. 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. Prior participation in a clinical study of OMS302.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 OMS302<br>OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution | Drug: Part 1 OMS302<br>* 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.<br>|
| Experimental: Part 2 OMS302<br>OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution | Drug: Part 2 OMS302<br>* 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.<br>|
| Placebo Comparator: Part 2 Placebo<br>Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution. | Drug: Part 2 Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pupil Diameter | Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR. | Intraoperative |