A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Glia, LLC
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fluorescein corneal staining
研究概览
简要总结
This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
详细描述
The clinical hypothesis is that CLM2 topical gel applied dermally on the forehead twice daily will be more effective than placebo (a) in reducing or eliminating ocular discomfort associated with contact lens wear, (b) prolong hours of comfortable wear, (c) prolong total hours of contact lens wear, (d) improve ease of insertion and removal of contact lens, and ( c) reduces friction between cornea/lens and lens/eyelid, without use of artificial eye drops or gels. One mechanism supporting this hypothesis is preliminary evidence of increased meibum secretion following CLM2 topical gel application.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
3-digit randomized number assignment with matching by age within 10 years, and within 5 years of lens wear. Study drug:placebo, 1:1.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race ≥18 years of age at Visit 1 Screening.
- •Has provided verbal and written informed consent.
- •Be able and willing to follow instructions, including participation in all study assessments and visits.
- •Has been wearing soft contact lens in both eyes at least 2 days per week for at least a month.
- •Duration of comfortable lens wear daily is less than desired.
- •Suffers from at least two other symptoms while wearing lens with contact lens discomfort of grade 2 or higher:
- •Blurred vision
- •Conjunctival redness
- •Lens awareness
- •Use of artificial tears or gels two or more times a day during contact lens wear hours.
- •Berkeley Dry Eye Flow Chart (DEFC) score ≥3.
排除标准
- •BCVA at baseline <20/
- •Wearing contact lens only in one eye.
- •Wearers of the following contact lenses: Extended wear, prosthetic, scleral, and intracorneal gas permeable.
- •Pregnant women or women of childbearing potential who are not using contraception.
- •Diagnosis of the following autoimmune diseases: Addison's disease, Grave's disease, Hashimoto's thyroiditis, lupus, and Sjogren's syndrome.
- •Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such dystrophies, infections, etc.
- •Has a condition or be in a situation that, the opinion of the investigator, that may interfere significantly with the subject's participation in the study. No active ocular condition or disease.
- •Has a known adverse reaction and/or sensitivity to either study drug or its components.
- •Unwilling to remove contact lens overnight.
- •Unwilling to attempt to wear contact lens seven (7) days a week during the study period.
- •Plan to change brand of contact lens during study period.
- •Unwilling to wear contact lens for at least 10 hours if comfort permits, or until discomfort requires removal of contact lens prior to 10 hours.
- •Unwilling to discontinue swimming with immersed head for the duration of the study.
- •Unwilling to withhold the use of artificial tears, gels, or wetting agents during periods when contact lens is worn during the study period.
- •Cannot withhold the following medications during the study period:
- •antihistamines, some diuretics, antidepressants, antipsychotics, Restasis, Xiidra, Accutane, glaucoma medications, other anti-cholinergics; as well as gabapentin.
- •Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
研究组 & 干预措施
CLM2 Topical Gel
CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
干预措施: CLM2 topical gel (Drug)
Placebo Topical Gel
Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
干预措施: Placebo topical gel (Drug)
结局指标
主要结局
Fluorescein corneal staining
时间窗: 21 days
Change in score (0-3 worst)
Hours of continuous comfortable contact lens wear
时间窗: 21 days
Change in total hours per day
Berkeley Dry Eye Flow Chart
时间窗: 21 days
Change in grade (1-5 worst)
Contact Lens Questionnaire-8 (CLDEQ-8)
时间窗: 21 days
Change in total score (0-37 worst)
次要结局
- Eye discomfort from CLDEQ-8, frequency(21 days)
- Eye discomfort from CLDEQ-8, intensity(21 days)
- Glia contact lens symptoms questionnaire(21 days)
- Fluorescein conjunctival staining(21 days)
- Tear film examination by TearScan(21 days)
- Tear film breakup time(21 days)
- Tear meniscus height(21 days)
- Visual acuity(21 days)
- Tear osmolarity(21 days)
- Schirmer test(21 days)