A Phase 4 Study to Assess the Clinical Efficacy of Nanomicellular Cyclosporine 0.09% Versus Lifitegrast 5.0% for Central Corneal Stain Clearing Over 90 Days
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Toyos Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in central corneal staining
研究概览
简要总结
This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.
详细描述
The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.
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
- Double (Participant, Investigator)
盲法说明
study medication will be provided in an unmarked box with tape externally covering any identifying language
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is able to read, understand and sign informed consent.
- •Provision of signed and dated informed consent and HIPAA authorization .
- •Willingness to comply with study procedures and availabilty for duration of study.
- •Aged 18-85, male or female
- •Minimum of 5 central corneal superficial punctate keratitis spots.
- •Normal eyelid anatomy
- •highly effective contraception for at least 1 month prior to screening and agreement to use effective contraception during study participation and for an additional 4 weeks after study drug discontinuation.
- •Postmenopausal or surgical sterilization.
排除标准
- •Known hypersensitivity or contraindication to investigational product.
- •Contact lens use within one month prior to screening
- •Unwilling to discontinue contact lens.
- •pregnancy or lactation.
- •topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.
- •Ocular surgery or eyelid surgery within 6 months prior to screening
- •Subjects can be on the following medications if they have been on a stable dose for 12 weeks: loteprednol, tetracycline, omega 3, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressives including oral steroids, non-steroidals, antihistamines, mast cell stabilizers, punctal plugs, corticotropin repository or glaucoma medications.
- •abstain from eyelast growth products containing prostaglandin
- •Must not have had penetrating intraocular surgery, refractive surgery, cornea transplant, eyelid surgery within 6 months prior to Visit 1
- •Febrile illness within 1 week
- •Treatment with another investigational drug or intervention within one month
- •History of herpetic keratitis.
- •Serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study study assessments or limit compliance.
- •Use of new prescription eyedrop within 90 days of screening.
- •Change in systemic medication within 90 days of screening
- •Anticipated relocation or extensive travel during study period. -
研究组 & 干预措施
Nanomicellular Cyclosporine 0.09 prior to surgery
50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery
干预措施: nanomicellular cyclosporine 0.09% (Drug)
Lifitegrast 5.0%
50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery
干预措施: Lifitegrast (Drug)
结局指标
主要结局
change in central corneal staining
时间窗: 90 days
use of fluorescein staining to count at slit lamp actual number of central cornea spk
次要结局
- change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning(90 days)
- change in corneal topography(90 days)
- change in Schirmers testing(90 days)