E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intraocular Lens Replacement (ILR) in subject at high risk for Intraoperative Floppy Iris Syndrome (IFIS) |
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E.1.1.1 | Medical condition in easily understood language |
Intraocular Lens Replacement |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054771 |
E.1.2 | Term | Intraocular lens replacement |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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.
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E.5.2 | 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).
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Part 1 will evaluate whether the proposed efficacy measurements such as intraoperative pupil diameter, pupil constriction, iris billowing and iris prolapse can be accurately measured in subjects at high risk of IFIS. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Part 1 is open-label. Part 2 is randomized, parallel-group, double-masked and placebo-controlled |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial for the OMS302-ILR-006 study will be defined as 60 days after final database lock. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |