NCT06482177已完成4 期
The COAT Trial: Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in corneal high order aberrations (HOA)
研究概览
简要总结
Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
详细描述
The purpose of this study is to examine the speed of onset of CEQUA ™ in improving the ocular surface among patients with dry eye.
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
- 是
入选标准
- •*Patients with the following signs: Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.
- •Able to comprehend and sign a statement of informed consent.
- •Willing and able to complete all required postoperative visits.
排除标准
- •Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- •Clinically significant ocular trauma.
- •Active ocular Herpes simplex or Herpes Zoster infection
- •Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
- •Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
- •Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
- •Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
- •Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- •Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
- •Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
- •Participation in this trial in the same patient's fellow eye
- •Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
研究组 & 干预措施
Dry Eye Disease
Other
Patient with dry eye disease
干预措施: Cyclosporine ophthalmic solution (Drug)
结局指标
主要结局
Change in corneal high order aberrations (HOA)
时间窗: After 7, 14, and 28 days of treatment
Change in corneal HOA
次要结局
- Change in corneal staining(After 7, 14, 28 days of treatment)
研究者
研究点 (1)
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