ACTRN12622001113741招募中未知
An adaptive, early-feasibility, open-label, pilot clinical study of ETX-4143 in subjects with chronic ocular pain
EyeCool Therapeutics, Inc0 个研究点目标入组 16 人开始时间: 2022年8月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 o limit（—）
- 性别
- All
入选标准
- •1)adult patients age 21 or older of any gender
- •2)At least moderate ocular surface discomfort (dryness, discomfort, grittiness, itchiness, burning, stabbing, shooting, or aching pain) that significantly improves with application of topical anesthetic in the to-be-treated eye, as per investigator assessment
- •3)Normal lid anatomy, blink, and closure as determined by the investigator
- •4)If a contact lens user, willingness to stay out of contact lenses in the treated eye for 24 hours pre- and post-procedure
- •5)Willingness to participate in the study as evidenced by signing of an informed consent document
排除标准
- •1)Pregnancy, breastfeeding, or planning to become pregnant or breastfeeding
- •2)Known allergy or hypersensitivity to copper, gold or aluminum.
- •3)Corneal Punctate Epithelial Erosions worse than 2+ in the to be treated eye as determined by Lissamine green or fluorescein staining using the Oxford Grading Scale
- •4)A history of corneal transplant (penetrating keratoplasty or endothelial keratoplasty), other significant corneal endothelial disease, or a history of keratoconus, corneal thinning, or other corneal ectasias
- •5)Any active ocular infection (bacterial, viral, or fungal), or active ocular inflammation, or any prior history of uveitis, at the time of the Screening Visit
- •6)A history of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to stem cell deficiency, diabetic keratopathy, lagophthalmos, topical anesthetic abuse, or any other cause
- •7)At Screening Visit, intraocular pressure (IOP) may not be less than 5 mmHg or be greater than 25 mmHg
- •8)Any history of significant prior conjunctival surgery (such as pterygium, trabeculectomy or scleral buckle surgery)
- •9)Planned eye surgery during the study period
- •10)Participation in any clinical study of an investigational product within 30 days prior to enrollment
- •11)Any change in dose in the last 30 days to a centrally acting neuromodulator (such as gabapentin, pregabalin, serotonin and norepinephrine reuptake inhibitors (SNRIs)), cannabinoid use, or to an ophthalmic anti-inflammatory drug (such topical cyclosporine (Restasis), lifitegrast (Xiidra), autologous serum tears, topical/oral steroids, or topical/oral non-steroidal anti-inflammatory drugs)
- •12)Any history of serious, poorly controlled systemic or ophthalmic condition or circumstances which, in the opinion of the Investigator, could compromise the subject’s ability to comply with the protocol or that could compromise the subject’s safety or the interpretation of the clinical trial results.
研究者
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