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临床试验/NCT07639034
NCT07639034已完成4 期

The Effectiveness of Systane PRO in Providing Relief From Multiple Symptoms of Dry Eye Disease and Its Impact on Daily Functioning and Overall Comfort in Patients With Mild to Moderate Dry Eye Disease

Gordon Schanzlin New Vision1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
33
试验地点
1

研究概览

简要总结

The primary objective of this study is to show that consistent use of Systane PRO over a 30 period will significantly improve the signs and symptoms of Dry Eye Disease and decrease patients' ocular surface disease index score for patients diagnosed with mild-moderate (DED).

详细描述

30 eligible participants with mild-moderate dry eye disease (DED) will be enrolled based on predefined Inclusion/Exclusion criteria. All assessments are performed on Day 0, capturing the initial status of several subject-reported symptoms and clinical features of DED. Participants will then commence daily administration of Systane PRO, QID, will be reassessed after 30 days of continuous use. All initial assessments will be repeated on Day 30 to generate paired data for all subject-reported and clinical data. This paired design will minimize cross-subject variability and improve the statistical power of the study.

Subject-reported symptoms of DED will be assessed by: the Ocular Surface Disease Index (OSDI) questionnaire, the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, Visual Analog Scale (VAS) Questionnaires for Ocular Stinging and Grittiness, and the Work Productivity and Activity Impairment (WPAI) questionnaire for DED. These instruments provide comprehensive insight into patient experience, capturing frequency, severity, and the daily impact of symptoms.

Clinical measurements include: LogMAR-converted Best-Corrected Distance Visual Acuity (BCDVA), Corneal Fluorescein Staining (NEI Scale), and Tear Breakup Time 6 of 13 (TBUT). Collectively, these clinical measurements will serve as secondary endpoints for this study and will be used to corroborate any changes observed in the primary endpoint, change in OSDI score.

Additionally, a Manifest Refraction will be performed once at baseline to assess BCDVA, the same refraction will be used to assess BCDVA at Day 30. A Wratten-12 filter will be utilized for Corneal Fluorescein Staining Grading and Tear Breakup Time assessments to facilitate accurate visualization of the tear film.

At study completion, changes from baseline in both subjective and objective measures are systematically analyzed according to the Statistical Analysis Plan.

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

入选标准

  • Patients aged 18 and older with mild-moderate DED (as determined by an OSDI score between 13-22).

排除标准

  • Patients unwilling to discontinue all concomitant ophthalmic medications and dry eye therapies for the duration of the study.

研究组 & 干预措施

The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and

Experimental

干预措施: Systane Pro Topical Ophthalmic (Drug)

研究者

发起方
Gordon Schanzlin New Vision
申办方类型
Other
责任方
Sponsor

研究点 (1)

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