NCT07277257招募中4 期
Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome
Center For Sight1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年12月2日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)
研究概览
简要总结
This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must fulfill the following conditions to qualify for enrollment into the trial
- •Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
- •History of using or desiring artificial tears for DED symptoms within the past 2 months.
- •Unanesthetized Schirmer's Test (UA ST) score ≥1 and < 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).
排除标准
- •Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- •History of ocular surgery within the past 6 months.
- •Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
- •On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
- •Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
- •Use of artificial tears within 2 hours prior to the baseline or study visit days.
- •Any known allergies to any component of the study drug.
- •Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included.
研究组 & 干预措施
Study eye
Experimental
The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit.
干预措施: TRYPTYR (Acoltremon ophthalmic solution 0.003%) (Drug)
结局指标
主要结局
Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)
时间窗: 3 minutes
Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform WorkDry EyeNCT07266948Southern College of Optometry40
Enrolling By Invitation
不适用
Moderate-to-Severe Dry Eye Disease Relief Using AcoltremonNCT07268599Colvard Kandavel Eye Center50
已完成
4 期
Treatment of Dry Eye Using 0.03% Tacrolimus Eye DropsSjogren SyndromeDry Eye SyndromeNCT01850979University of Sao Paulo General Hospital24
招募中
3 期
Low-dose AtropIne for Myopia control in children2024-513091-17-00Medical Center - University Of Freiburg300
已完成
3 期
Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's SyndromeSjogren's SyndromeAutoimmune DiseasesDry EyeNCT01601028Seoul National University Hospital39