NCT01765972已完成不适用
Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
研究概览
简要总结
The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- •The subject must be between 18 and 45 years of age.
- •The subject must be an adapted soft contact lens wearer in both eyes.
- •The subject must be of East or Southeast Asian descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. (it is preferred but not required that both the subject's biological parents are East or Southeast Asian ethnicity, by self report).
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D in each eye.
- •The subject's refractive cylinder must be no more than 1.00D in each eye.
- •The subject must have best corrected visual acuity of +0.14 logMAR (equivalent to 20/25-2) or better in each eye.
- •Subjects must own a wearable pair of spectacles and wear them on the day of the initial visit, during the washout before each phase and during the no lens wear phase.
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Are currently pregnant or lactating by self report (subjects who become pregnant during the study will be discontinued).
- •Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to, diabetes. hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, HIV/AIDS, hepatitis, and tuberculosis.
- •Use of any topical medications such aas eye drops or ointments.
- •Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion, or aphakia.
- •Had any previous, or planned ocular or intraocular surgery (e.g. cataract surgery, radial keratotomy, PRK, LASIK, etc.).
- •Have any grade 2.0 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear.
- •Have any known hypersensitivity or allergic reaction to one of the study products.
- •Have any ocular infection.
- •Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •Have any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV by self report).
- •Currently wear their contact lenses on an extended wear basis.
- •Are an employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
结局指标
主要结局
Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
时间窗: 8 hours post fit
Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry EyeDry EyeNCT05692739Barbara Burgos Blasco116
撤回
2 期
OSIG-eye Drops Treatment for Dry Eye DiseaseDry EyeNCT04510428University of Illinois at Chicago
已完成
不适用
Clinical Comparison of 4 Daily Disposable Soft Contact LensesRefractive ErrorNCT03349632Alcon Research68
已完成
不适用
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact LensCorneal DeformityNCT02258139Bausch & Lomb Incorporated38
已完成
不适用
EYEFILL® C. -US Viscoelastic Clinical InvestigationCataractNCT02024711Bausch Health Americas, Inc.262