Assessing the Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Treatment in Patients With Neuropathic Corneal Pain (NCP)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by corneal nerve regeneration.
研究概览
简要总结
This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. All patients will be evaluated for clinical symptoms and signs of NCP, corneal staining and nerve regeneration (by IVCM) at Baseline (Visit 2) through the end of study (16 weeks post treatment).
详细描述
During the screening (Visit 1 / Day -8) all procedures for inclusion will be performed. From the day of screening the participants will stop any kind of further previous ocular treatment regime, except commercially available preservative free artificial tears provided by Sponsor for 7 days and 9 days as maximum (day -8 to day -1+2) until the baseline(Visit 2) . At the end of the washout period (day -8 to day -1+2), participants meeting the entry criteria for this study will be assigned to receive the Oxervate® at 4times/daily dosing in both eyes for 4 weeks.
At Week 1, participants will be queried for adverse events. If the participant reports side effects while on 4times/daily dosing, subjects will be instructed to begin a modified dosing regimen: 4 times daily for 3 days, then 1 day off dosing. At Week 4, participants will be evaluated for clinically significant changes. If resolution of NCP or improvement is observed, Oxervate® will be discontinued. If there is partial/no-improvement, participants will be instructed to begin an increased dosing regimen of 6times/daily. If at any point during the intervention period ocular pain/irritation is worsened for a prolonged period, Oxervate® intervention will be discontinued.
During the 8 weeks of intervention, only the administration of Oxervate® is allowed. Nevertheless, if strictly needed, the participant can take preservative free artificial tears (provided by Sponsor). The use (n° drops/day) of preservative free artificial tears will be clearly documented in a participant's diary and in the CRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
- •Positive ICVM findings
- •If female with childbearing potential, have a negative pregnancy test
- •Best corrected distance visual acuity, 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
- •Ability to speak and understand the English language sufficiently to understand the study, provide written consent, and allow completion of all study assessments
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
- •History of severe systemic allergy or severe ocular allergy
- •Inability to suspend topical medications during the duration of the study
- •Inability to suspend oral medications for NCP.
- •No changes 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 patients that are pregnant/have a positive pregnancy test result/are breast-feeding/intend to become pregnant during the study treatment period
- •Drug addiction/alcohol abuse within the last year
- •Participation in another clinical trial
研究组 & 干预措施
Oxervate® (cenegermin)
OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj
干预措施: Cenegermin-Bkbj (Drug)
结局指标
主要结局
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by corneal nerve regeneration.
时间窗: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Quantifying total number of nerves of the corneal subbasal nerve plexus through in vivo confocal microscopy IVCM), summation of main trunk and branch nerves in one image reported as frame/nerve. Change from baseline in nerve quantity on IVCM at 16 weeks.
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular inflammation on in vivo confocal microscopy
时间窗: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Change in dendritic cell density on in vivo confocal microscopy from baseline to 16 weeks. The total nerve density will be assessed as the total nerve length in micrometers per image frame area (0.16mm\^2), from the three best representative images of each eye.
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular redness using the McMonnies/Chapman-Davies (MC-D) grading scale.
时间窗: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in grade of conjunctival hyperemia and bulbar conjunctival redness using the McMonnies/Chapman-Davies (MC-D) scale 0-1-2-3-4-5, 0 being absent conjunctival redness and 5 being severe conjunctival hyperemia
次要结局
- Occurrence of treatment-related adverse events assessed by severity and temporal relationship of study treatment.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Changes in corneal nerve function as assessed by hyperosmolar eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Efficacy of OXERVATE 0.002% at a reduced-dose regime (3 days on/1 day off) in patients reporting ocular side-effects/ocular pain assessed by changes in ocular inflammation on in vivo confocal microscopy.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Change in the stability of the tear film as assessed by Tear Film Break Up Time (TFBUT), change from baseline measurement at 16 weeks.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Changes in ocular surface integrity as assessed by NEI corneal staining scale, changes in corneal fluorescein staining from baseline at 16 weeks.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Tolerability of OXERVATE 0.002% on neuropathic corneal pain as assessed by the ocular surface disease index (OSDI) questionnaire, change from baseline ocular symptom score on OSDI(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Patient Reported outcome on quality of life dimensions of OXERVATE 0.002% on neuropathic corneal pain as assessed by Ocular Pain Assessment Survey (OPAS), change from baseline ocular pain score on OPAS(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Efficacy of OXERVATE 0.002% at an increased-dose regime (6times/daily) for 4 weeks assessed by changes in ocular inflammation on in vivo confocal microscopy.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Resolution of peripheral pain component as assessed by proparacaine eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.(From Baseline Visit to End of Study Visit (16 weeks post treatment))
- Changes in aqueous tear production as assessed by Schirmer's II test, change from baseline measurement at 16 weeks.(From Baseline Visit to End of Study Visit (16 weeks post treatment))