Intraocular Lens Replacement (ILR) in subject at high risk for Intraoperative Floppy Iris Syndrome (IFIS) MedDRA version: 17.0 Level: LLT Classification code 10054771 Term: Intraocular lens replacement System Organ Class: 100000004865
Conditions
Interventions
Product Code: OMS302
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: PHENYLEPHRINE HYDROCHLORIDE
CAS Number: 61-76-7
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Omeros Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects may be included in the study only if they meet all of the following criteria within 28 days prior to the day of surgery: 1. Competent to provide informed consent. 2. Voluntarily provide informed consent and HIPAA Authorization in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for any of the following reasons: 1. Hypersensitivity to phenylephrine, ketoprofen, or other NSAIDs, including aspirin. 2. Hypersensitivity to tetracaine, lidocaine, Duovisc® 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 than 110 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of Part 1 of the study is to evaluate whether intraoperative pupil diameter can be accurately measured in subjects at high risk for Intraoperative Floppy Iris Syndrome (IFIS). The primary objective of Part 2 of the study is to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during intraocular lens replacement in subjects at high risk for IFIS on: • Intraoperative pupil diameter. ;Secondary Objective: The secondary objectives of Part 2 of the study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during intraocular lens replacement in subjects at high risk for IFIS on: • Incidence of pupillary constriction greater than or equal to 2.5mm at any time during the ILR procedure • Incidence of absolute pupillary diameter less than 6mm any time during the ILR procedure • Incidence of iris billowing during the ILR procedure • Incidence of iris prolapse during the ILR procedure and • Safety as measured by adverse events. ;Primary end point(s): • Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) determined by video capture during ILR.;Timepoint(s) of evaluation of this end point: Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) is determined by video capture during ILR. Pupil diameter during the surgical procedure will be measured every minute. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pupillary constriction greater than or equal to 2.5 mm at any time during the ILR procedure 2. Pupillary diameter less than 6 mm at any time during the ILR procedure 3. Iris billowing during the ILR procedure 4. Iris prolapse during the ILR procedure 5. Safety as assessed by the incidence of adverse events (AE) and serious adverse events (SAE). ;Timepoint(s) of evaluation of this end point: The incidence of pupil constriction greater than or equal to 2.5 mm and pupil diameter less than 6 mm at any time during the ILR procedure will be assessed. The incidence of iris billowing and iris prolapse during the ILR procedure will also be assessed. Iris prolapse and iris billowing will be determined by a masked ophthalmologist central reader reviewing the surgical videos. Safety and tolerability will be assessed based on adverse events and serious adverse events as well as ocular and systemic measures for seven days postoperatively. | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Operations Coordinator
Iris Pharma
Outcome results
None listed