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临床试验/NCT05109702
NCT05109702已完成3 期

A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% Compared to Placebo in Subjects With Dry Eye

HanAll BioPharma Co., Ltd.10 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2021年11月18日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
260
试验地点
10
主要终点
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.

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
Triple (Participant, Care Provider, 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

  • •Have a participant-reported 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
  • •Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1
  • •Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort & 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2
  • •Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2
  • •Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2
  • •Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2

排除标准

  • •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
  • •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
  • •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
  • •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
  • •Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
  • •Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution
  • •Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
  • •Be a woman who is pregnant, nursing or planning a pregnancy

研究组 & 干预措施

Placebo Run-in

Other

Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.

干预措施: Placebo (Drug)

0.25% Tanfanercept Ophthalmic Solution

Experimental

Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.

干预措施: 0.25% Tanfanercept Ophthalmic Solution (Drug)

Placebo

Placebo Comparator

Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.

干预措施: Placebo (Drug)

结局指标

主要结局

Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57

时间窗: Baseline, Day 57 (Week 8)

CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.

Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57

时间窗: Baseline, Day 57 (Week 8)

Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

次要结局

  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8(Baseline; Weeks 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8(Baseline; Weeks 1, 2, 4, and 8)
  • Ora Calibra® Drop Comfort Assessment at Week 1(Week 1)
  • Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort(Baseline; Weeks 1, 2, 4, and 8)
  • Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort(Baseline; Weeks 1, 2, 4, and 8)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (10)

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