NCT02093689终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Pupil Diameter
研究概览
简要总结
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Part 1 OMS302
Experimental
OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
干预措施: Part 1 OMS302 (Drug)
Part 2 OMS302
Experimental
OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
干预措施: Part 2 OMS302 (Drug)
Part 2 Placebo
Placebo Comparator
Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.
干预措施: Part 2 Placebo (Drug)
结局指标
主要结局
Change in Pupil Diameter
时间窗: Intraoperative
Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With PhacoemulsificationIntraocular Lens ReplacementNCT01579565Omeros Corporation416
已完成
3 期
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With PhacoemulsificationIntraocular Lens ReplacementNCT01454063Omeros Corporation405
已完成
1 期
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.Cataract ExtractionNCT00721695Omeros Corporation60
终止
2 期
Safety and Efficacy of OMS643762 in Subjects With Huntington's DiseaseHuntington's DiseaseNCT02074410Omeros Corporation22
已完成
2 期
Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia SubjectsSchizophreniaNCT01952132Omeros Corporation40