Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
研究概览
简要总结
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic 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
- •Healthy male or female subject ≥18 years of age
- •Presence of moderate DED in at least one eye
排除标准
- •Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
- •Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- •External eye disease except primary DED
- •Systemic disease associated with DED
- •History or evidence of ocular infection within the previous 30 days
- •History or evidence of ocular herpes simplex or ocular herpes zoster
- •Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
研究组 & 干预措施
INV-102 0.7% Three times daily (TID)
Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks
干预措施: INV-102 (Drug)
Vehicle
Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks
干预措施: Vehicle (Drug)
INV-102 0.7% BID
Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks
干预措施: INV-102 (Drug)
INV-102 0.25% BID
Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks
干预措施: INV-102 (Drug)
INV-102 TBD% BID
Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4
干预措施: INV-102 (Drug)
INV-102 0.1% Twice daily (BID)
Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks
干预措施: INV-102 (Drug)
结局指标
主要结局
Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
时间窗: Day 15
Change from Baseline to Day 15 in either the Eye Dryness Score -OR- Eye Discomfort Score from the 7-item DED symptom VAS (specific outcome measure for Part 2 will be chosen based on results from Part 1, Cohorts 1 to 4)
Part 1: Characterize the safety profile of INV-102
时间窗: Through study completion (Day 22)
Incidence rate of treatment emergent adverse events (TEAEs)
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event
时间窗: From first dose through study completion (Day 22)
The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens.
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)
时间窗: Day 15
The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms.
次要结局
- Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score(Day 15)
- Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score(Day 15)