A Phase 2a, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Assess ocular pain using 0-10 visual analog scale (VAS)
研究概览
简要总结
The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).
详细描述
Detailed Description: Neuropathic corneal pain (NCP) is a complex disease affecting the somatosensory nervous system characterized by different underlying etiologies and pathogenesis.
OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and neuropathic corneal pain; and is designed to combat washout through the inclusion of the lipid 'anchor' contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment. Our preclinical studies have shown that treatment with OK-101 abolishes corneal pain in a murine model of NCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a randomized, double-masked, placebo-controlled trial to investigate the efficacy of OK101 study drug in treating the symptoms of NCP at baseline (Visit 1) through the end of study (16 weeks) in NCP subjects.
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
- •Male or female aged ≥ 18 years.
- •Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain.
- •Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas.
- •Females of childbearing potential must have a negative pregnancy test.
- •Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200).
- •Satisfying all Informed Consent requirements.
- •Ability and willingness to comply with study procedures.
排除标准
- •Evidence of any active ocular infection.
- •Evidence of any intraocular inflammation.
- •Evidence of any persistent epithelial defect/ulcer.
- •Evidence of any corneal scar/corneal edema.
- •Presence of any other ocular conditions that require topical medications during the treatment phase.
- •History of severe systemic allergy or severe ocular allergy.
- •Inability to suspend topical medications 8 days prior to the starting date.
- •Inability to continue oral medications for NCP without changes during the study duration.
- •No changes or less than 50% improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
- •History of any ocular surgery within three months before study Visit 1(day 0).
- •Ocular surgery expected during the 16 weeks of the trial.
- •Use of refractive/therapeutic contact lenses during the study period.
- •Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
- •Drug addiction/alcohol abuse within the last year.
- •Participation in another clinical trial concurrently.
研究组 & 干预措施
Arm A
OK-101, 0.05% - one drop of study drug (0.05%) will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks
干预措施: OK-101 0.05% (Drug)
Arm B
OK-101, 0.1% - one drop of study drug (0.1%) will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks.
干预措施: OK-101 0.1% (Drug)
Arm C
Placebo - one drop of placebo will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Assess ocular pain using 0-10 visual analog scale (VAS)
时间窗: 16 Weeks
Visual analog scale questionaire will be used to evaluate the pain on 0-10 scale where 0 is no pain and 10 is worst pain imaginable.
次要结局
- Ocular Pain Assessment Survey (OPAS) scores(16 Weeks)
- Ocular Surface Disease Index (OSDI©) scores(16 Weeks)
- QoL Improvement assesed by OPAS score(16 Weeks)
- Drop comfort Scores(16 Weeks)