A Randomized, Double-masked, Vehicle-controlled Study of LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when administered topically for up to 42 days, in subjects with severe dry eye disease.
详细描述
This study is organized into 2 phases. Following a 2-week identification phase, eligible subjects with severe dry eye disease (DED) will be randomized into the treatment phase and will be dispensed study treatment for 10 weeks.
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)
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
- •Must sign written informed consent.
- •Physician diagnosis of DED of at least 6 months prior to Visit
- •Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis.
- •Respond as "often" or "constantly" to the question "How often do your eyes feel uncomfortable?".
- •Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS at Visit
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Presence of any acute infection or non-infectious ocular condition in either eye within 1 month of Visit
- •Contact lens wearers, defined as individuals who cannot be without their contact lenses for the entire duration of the study.
- •Any chronic ocular degenerative condition that in the opinion of the Investigator could possibly advance during the time course of the study.
- •Use of biologics treatments, such as systemic biologic anti-cytokines, including anti-TNFα drugs, or immunosuppressive therapy for the treatment of severe systemic autoimmune disorders.
- •Diseases or conditions affecting the ocular surface that are associated with clinically significant scarring and or destruction of conjunctiva and/or cornea.
- •Unwilling to abstain from topical ocular non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc. after Visit
- •Use of nasal, inhaled, systemic (including injections), or topical corticosteroids within 30 days of Visit
- •Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: Baseline (Day 43), Day 57, Day 71, Day 85
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.
Mean Change From Baseline in Global Ocular Discomfort Score at Day 71
时间窗: Baseline (Day 43), Day 71
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Intraocular Pressure (IOP)
时间窗: Baseline (Day 43), Day 57, Day 71, Day 85
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.
Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit
时间窗: Baseline (Day 43), Day 57, Day 71, Day 85
The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.
Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit
时间窗: Baseline (Day 43), Day 57, Day 71, Day 85
Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.
次要结局
- Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71(Baseline (Day 43), Day 71)
- Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)(Day 15, Day 29, Day 43, Day 57, Day 71, Day 85)
- Percentage of Subjects With Anti-LME636 Antibodies by Visit(Day 15, Day 29, Day 43, Day 57, Day 71, Day 85)