NCT04240587撤回不适用
Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
研究概览
简要总结
To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age at screening visit
- •Ocular Surface Disease Index (OSDI) score of less than 12 (without contact lens wear)
- •Contact Lens Dry Eye Questionnaire (CLDEQ)-8 score of greater than 12.18
- •Regular contact lens wearer who wears them less than 6 hours per day due to discomfort
- •The presence of at least one microneuroma on in vivo confocal microscopy
- •Self-reported good compliance with healthy contact lens regimen (replace contact lenses per manufacturer's recommendations, use of multipurpose or hydrogen peroxide contact lens solution nightly)
- •Have had an eye exam within the last two years that included dispense of a contact lens prescription
- •Proparacaine drops relieve at least 75% of ocular symptoms to ensure that patients do not have centralized neuropathic corneal pain
- •If a soft lens wearer, use a contact lens that was released within the last 15 years
排除标准
- •Use of topical drops other than artificial tear substitutes
- •Ocular surgery or other ocular disease within 3 months prior to study enrollment
- •Concurrent ocular disease that may impact results
- •Have dry eye (as defined by 2 or more of the parameters below)
- •Schirmer's wetting test < 10mm
- •TBUT <7sec
- •NEI scale corneal staining of 4 out of 15 at the time of enrollment
- •Improper CL fit
- •No microneuroma by in vivo confocal microscopy
- •Overnight wear within 1 month of screening visit
- •Use of colored or cosmetic lenses
- •Contra-indication to ITN
- •Chronic or recurrent epistaxis, coagulation disorders.
- •Nasal or sinus surgery or significant trauma to the nose.
- •Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
- •Chronic or recurrent nosebleeds
- •Bleeding disorder
- •Known hypersensitivity (allergy) to the hydrogel material
- •Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.
- •History of migraines
- •Under 21 years of age
结局指标
主要结局
To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
时间窗: 3 months
To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment
时间窗: 3 months
To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment
时间窗: 3 months
次要结局
- To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.(3 months)
- To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.(3 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal NeurostimulationDry Eye SyndromesNCT02910713Allergan185
终止
不适用
Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal PainCorneaNCT03674892Tufts Medical Center21
已完成
不适用
Exploring nasal neurostimulation for managing contact lens discomfortContact lens discomfortEye - Diseases / disorders of the eyeACTRN12615000745549Associate Professor Jennifer P. Craig30
已完成
不适用
Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry EyeDry Eye SyndromesDry EyeNCT05887336Abilion Medical Systems AB106
尚未招募
4 期
Efficacy Of Intranasal Tapentadol In Pain Management In Opioid Use DisorderCTRI/2021/09/036462GMC RH Patiala