NCT05992922终止2 期
A Phase 2, Single-Center, Randomized, Double- Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution 1% in Subjects Diagnosed With Dry Eye Disease
Iacta Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular Discomfort and Dry Eye Symptoms
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle in participants with signs and symptoms dry eye disease.
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)
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
- •Be at least 18 years of age;
- •Provide written informed consent
- •Have a reported or documented history of dry eye for at least 6 months prior to Visit 1
- •Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
- •Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one symptom at Visits 1 and 2
- •Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2
- •Have a pre-CAE(controlled adverse environment) (conjunctival redness score ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2
- •Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) at Visits 1 and 2
- •Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions at Visits 1 and 2
- •Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at Visits 1 and 2
- •Demonstrate a response to the CAE at Visits 1 and 2 as defined by:
- •Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure
- •Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) Note: a subject cannot have an ocular discomfort score of 4 at time = 0)
排除标准
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment
- •Have any clinically significant (CS) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the Investigator may interfere with study parameters
- •Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact lenses during the study
- •Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period
- •Have had any surgeries of the ocular surface or lid in the past 6 months
- •Have a history of lacrimal duct obstruction in either eye within 12 months prior to Visit 1
- •Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or anticipate their use during the study period
- •Have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such event at any time during the study period
- •Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study
研究组 & 干预措施
IC265 Ophthalmic Solution 1%
Experimental
1 drop will be instilled in each eye twice daily.
干预措施: IC265 Ophthalmic Solution 1% (Drug)
Placebo Ophthalmic Solution (Vehicle)
Placebo Comparator
1 drop will be instilled in each eye twice daily.
干预措施: Placebo Ophthalmic Solution (Vehicle) (Drug)
结局指标
主要结局
Ocular Discomfort and Dry Eye Symptoms
时间窗: Change from Baseline Post-CAE® (controlled adverse environment) Day 15
Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
次要结局
未报告次要终点
研究者
研究点 (1)
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