NCT07838506尚未招募3 期
A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod (Formerly Called OK-101) Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- The change from baseline at Week 12 in ocular pain assessed by VAS score.
研究概览
简要总结
This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).
详细描述
This research study is to evaluate the safety of Urcosimod Ophthalmic Solution and its effect on the quality of life and vision in participants with Neuropathic Corneal Pain (NCP). The purpose of this research study will see if urcosimod can safely and effectively relieve the signs and symptoms of NCP, and whether it causes any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The randomization code will be computer-generated by the Sponsor designee. Randomization team members will not be involved in the day-to-day conduct of the study and work independently of the study team. Study personnel, study participants, the Sponsor, and project teams at the clinical research organization(s) (CRO) involved in the study will be masked to IMP assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years of age or older.
- •Able and willing to provide written informed consent prior to any study-related procedures.
- •Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptoms of burning, stinging, light sensitivity or discomfort.
- •In at least one eye:
- •Ocular pain score of 5 or more on 0-10 Visual Analogue Scale (VAS) AND in the same eye
- •In Vivo Confocal Microscopy (IVCM) changes of the subbasal corneal nerve plexus assessed by an Investigator who has received study-specific training.
- •Female participants must be one of the following: a) postmenopausal (defined as no menses for 1 year), b) surgically sterilized, c) practicing abstinence as a lifestyle choice (not as a form of contraception), or d) consistently and correctly using protocol-specified birth control for the duration of the study (e.g., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide; see Appendix 3).
- •Female participants who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test at the Screening and Day 1/Baseline visits.
- •Best corrected distance visual acuity (BCDVA), in the study eye of at least Snellen >20/
- •Participants that require topical ophthalmic medications during the study may be included if the medications are not topical ophthalmic blood-derived products, amniotic-membrane derived medications, cenegermin (Oxervate®), topical ophthalmic anti-allergic, anti-inflammatory, immunosuppressive and immunomodulators such as lifitegrast, and the dose has been stable for at least 3 months prior to Screening and is expected to remain stable throughout the study period.
- •Ability and willingness to comply with study procedures.
排除标准
- •Participants who meet any of the following criteria at Visit 1/Screening or Visit 2/Baseline will be excluded from the study.
- •Evidence of any active ocular infection (bacterial, viral, fungal or protozoal) in either eye.
- •Evidence of any intraocular inflammation defined as anterior chamber flare > 0 and/or cells >0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
- •Presence of any other ocular surface condition that may cause ocular pain including confluent punctuate staining, any corneal epithelial defect or ulcer, angle-closure glaucoma or uveitis, in either eye.
- •Presence of eyelid abnormalities such as trichiasis and lagophthalmos that can be the primary cause of corneal epithelial damage and ocular pain.
- •Evidence of any elevated corneal scars/corneal edema.
- •Any other concomitant medical condition that, in the judgment of the Principal Investigator (PI), might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being.
- •Use of topical ophthalmic calcineurin inhibitors such as Cyclosporin A, tacrolimus, pimecrolimus, or cenegermin (Oxervate®) in either eye in the 4 weeks prior to Visit 1/Screening visit.
- •History of severe systemic allergic condition or severe ocular allergy.
- •Inability to suspend use of intranasal tear secretagogues such as varenicline or device for dry eye at Visit 1/Screening and throughout the study period.
- •Inability to suspend prohibited ocular topical medications at Visit 1/Screening.
- •Inability to suspend use of blood-derived ocular treatments (e.g., autologous serum tears, platelet-rich plasma, etc.) or amniotic membrane-derived products at Visit 1/Screening visit.
- •Inability to continue stable (for at least 3 months) oral medications for NCP without changes during the entire study period.
- •No change or less than 50% improvement in ocular pain assessed by VAS score after topical anesthetic challenge.
- •History of any ocular surgery within 3 months prior to Visit 1/Screening.
- •Any anticipated ocular surgery during the entire study period.
- •Inability to suspend use of refractive/therapeutic contact lenses (including scleral lenses), botulinum toxin or electro/magnetic stimulation devices on the eye, face or scalp, during the entire study period.
- •Prior use of periocular or ocular botulinum toxin (Botox) within 3 months of Visit 1/Screening.
- •Evidence of current drug or alcohol abuse or addiction.
- •Participated in or used the investigational agent in another clinical study, within 30 days prior to Visit 1/Screening.
- •Known hypersensitivity to any of the components of the study drug, preservative-free artificial tears or procedural medications (e.g., fluorescein, anesthetic drops, etc.).
- •Previous participation in a clinical study or extended access program with urcosimod eye drops.
研究组 & 干预措施
Urcosimod Ophthalmic Solution
Experimental
• Urcosimod 0.05% - one drop in affected eye(s), four times a day
干预措施: Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. (Drug)
Vehicle ophthalmic solution
Placebo Comparator
Vehicle - one drop in affected eye(s), four times a day.
干预措施: Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. (Drug)
结局指标
主要结局
The change from baseline at Week 12 in ocular pain assessed by VAS score.
时间窗: From baseline (time of randomization) compared to Week 12.
Evaluate the efficacy and safety of urcosimod 0.05% as compared to placebo instilled 4 times/day in participants who have a documented ocular history of symptoms of neuropathic corneal pain.
次要结局
- Change from baseline at Week 12 in Quality-of-Life scores (7 QoL questions from OPAS survey).(Baseline visit compared to Week 12.)
- Change from baseline at Weeks 4, 8, and 16 in ocular pain assessed by VAS score.(Baseline visit compared to Weeks 4, 8 and 16.)
- Change from baseline at Week 2 in ocular pain assessed by VAS score in the participant diary.(Baseline visit compared to Week 2 of treatment period.)
研究者
研究点 (1)
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