E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intraocular Lens Replacement with Phacoemulsification |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054771 |
E.1.2 | Term | Intraocular lens replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 co-primary objectives of this study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on: Intraoperative pupil diameter and Pain during the early postoperative period. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on: Postoperative photophobia as measured by the photophobia subscale of the Numerical Rating System (NRS), Postoperative best-corrected visual acuity (BCVA), Postoperative inflammation as measured by Summed Ocular Inflammation Score (SOIS), Pain after the early postoperative period, Safety as measured by adverse events and the Systemic pharmacokinetics of PE and KE. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Competent to provide informed consent.
2. Voluntarily provide informed consent and HIPAA Authorization in accordance with local regulations and governing 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 18 years of age or older at the time of surgery.
5. Are to undergo unilateral primary CELR or RLE, under topical anesthesia, with a coaxial phacoemulsification device with insertion of an acrylic 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. For women of childbearing potential, have a negative urine pregnancy test. Women of childbearing potential (i.e., not surgically sterilized nor post-menopausal longer than 1 year) must agree to use a medically reliable form of contraception throughout the study as necessary. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception or a spermicide in combination with a barrier method. |
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E.4 | Principal exclusion criteria |
1. Hypersensitivity to phenylephrine, ketoprofen, or other NSAIDs, including aspirin.
2. Hypersensitivity to moxifloxacin (Vigamox®) or any other fluoroquinolone.
3. Hypersensitivity to tetracaine, lidocaine, Duovisc® or latex.
4. Women who are nursing a child or plan to nurse a child during the study.
5. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory or other medical condition as determined by the Investigator.
6. Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis, fibromyalgia).
7. Presence of systolic blood pressure of ≥160 mmHg or ≤90 mmHg, or diastolic blood pressure of ≥110 mmHg or ≤40 mmHg at the screening visit.
8. Use of phenylephrine (other than for the screening ophthalmological examination), NSAIDs, including ketorolac, or cyclosporine within 7 days prior to the day of surgery.
9. Use of topical, inhaled or oral corticosteroids within 7 days prior to surgery, or depot corticosteroids within 30 days of surgery.
10. Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery.
11. Use of ocular mast cell stabilizers within 7 days prior to surgery (Appendix 19.2).
12. Repeated use of pilocarpine in the study eye within 6 months prior to the day of surgery.
13. History of use of an alpha -1- adrenergic antagonist, such as tamsulosin (Flomax®), silodosin (Rapaflo®), prazosin (Minipress®, Hypovase®), alfuzosin (Uroxatral®), doxazosin (Cardura®) or terazosin (Hytrin®) (Appendix 19.2).
14. Presence of narrow-angle glaucoma or unstable glaucoma.
15. Glaucoma being treated with prostaglandins or prostaglandin analogues such as Xalatan®, Lumigan®, Travatan®, and Rescula®, or Alphagan® (brimonidine tartrate) in either eye during the 7 days prior to screening and through Day 14 postoperatively (Appendix 19.2).
16. Anticipated to require the use of other topical ocular medications in either eye through Day 14 postoperatively except ketorolac, corticosteroids, prophylactic antibiotics, topical lid care, allowed glaucoma medications or non-prescription tear replacement solutions.
17. Presence of pseudo-capsular exfoliation in either eye.
18. History of iritis, or of any ocular trauma with iris damage in the study eye.
19. Presence of uncontrolled chronic ocular diseases in either eye that could affect pupil dilation or confound the analysis of pain.
20. Presence of active corneal pathology or active scarring noted in either eye (except superficial punctate keratopathy in the non-study eye). Healed peripheral corneal incisions performedduring prior refractive surgical procedures are not considered scars.
21. Presence of extraocular/intraocular inflammation in either eye.
22. Presence of active bacterial and/or viral infection in either eye.
23. Participating in any investigational drug or device trial within the 30 days prior to the day of surgery.
24. History of intraocular non-laser surgery in the study eye within the 3 months prior to the day of surgery, or intraocular laser surgery in the study eye within 30 days prior to the day of surgery.
25. Requiring or planning other ocular surgery through Day 14 postoperatively.
26. Presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of the study data.
27. 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.
28. 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. Postoperative pain as measured by the Visual Analog Scale (VAS) at 2, 4, 6, 8 and 10-12 hours after ILR surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The co-primary endpoints are: 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. Postoperative pain as measured by the Visual Analog Scale (VAS) at 2, 4, 6, 8 and 10-12 after ILR surgery.
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E.5.2 | Secondary end point(s) |
Safety as assessed by the incidence of adverse events (AE) and serious adverse events (SAE) through Day 90. Proportion of subjects having a pupil diameter > 6mm at cortical clean-up. Proportion of subjects having a pupil diameter ≥ 6mm anytime during surgery. Proportion of subjects reporting moderate-to-severe pain (VAS ≥ 40) at any timepoints during 12 hours postoperatively. Proportion of subjects reporting no pain (VAS=0) at all timepoints during 12 hour postoperatively. Photophobia as measured by the NRS at 2, 6, 24, and 48 hours, and 7 and 14 days after surgery. Postoperative inflammation as measured using the SOIS at 24, and 48 hours, and 7, 14 and 90 days after surgery. Best-corrected visual acuity (BCVA) as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) method at 24 and 48 hours, and 7, 14 and 90 days after surgery. Pharmacokinetic measures.Postoperative pain as measured by the Visual Analog Scale (VAS) at 24 and 48 hours, and Days 3-7 and 14 after ILR surgery
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints are: Postoperative pain as measured by the Visual Analog Scale (VAS) at 24 and 48 hours, and Days 3-7 and 14 after ILR surgery Safety as assessed by the incidence of adverse events (AE) and serious adverse events (SAE) through Day 90. Proportion of subjects having a pupil diameter > 6mm at cortical clean-up. Proportion of subjects having a pupil diameter < 6mm anytime during surgery.
Proportion of subjects reporting moderate-to-severe pain (VAS ≥ 40) at any timepoints during 12 hours postoperatively. Proportion of subjects reporting no pain (VAS=0) at all timepoints during 12 hour postoperatively. Photophobia as measured by the photophobia scale of the |
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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 | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Netherlands |
United States |
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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 Trial for the OMS302-ILR-004 study will be defined as 60 days after the Final Database Lock (including all subject data through Day 90) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |