Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease
2026年7月23日 更新者：Jose Navarro Partida、Instituto Internacional de Medicina y Terapia (IIMET)
Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease: A Randomized Controlled Non-Inferiority Trial
The goal of this clinical trial is to learn whether a twice-daily dosing schedule of Systane Complete eye drops works as well as a four-times-daily dosing schedule of Thealoz Duo eye drops to treat dry eye disease in adults. The main questions it aims to answer are:
- Does twice-daily Systane Complete provide similar improvement in dry eye symptoms, measured by the Ocular Surface Disease Index (OSDI), compared with four-times-daily Thealoz Duo after 30 days of treatment?
- How do the treatments affect tear film stability, tear production, and damage to the surface of the eye?
Researchers will compare Systane Complete (used twice a day) to Thealoz Duo (used four times a day) to see if the simpler dosing schedule maintains similar benefits for symptoms and eye surface health.
Participants will be adults with mild to moderate dry eye disease who are seen in an outpatient eye clinic. They will be randomly assigned to one of the two treatment groups. All participants will use their assigned eye drops in both eyes for 30 days and will attend clinic visits at the start of the study and after 30 days. At each visit, participants will complete the OSDI questionnaire and undergo standard eye tests, including tear break-up time, Schirmer test, and grading of surface staining on the eye.
研究概览
研究类型
介入性
注册 (实际的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Jalisco
-
Zapopan、Jalisco、墨西哥
- Hospital Puerta de Hierro
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults (≥18 years of age) with mild to moderate dry eye disease (DED).
- Ocular Surface Disease Index (OSDI) score between 13 and 32 at baseline.
At least one abnormal objective test of ocular surface dysfunction, defined as one or more of the following:
- Schirmer test result < 10 mm in 5 minutes (without anesthesia), or
- Tear break-up time (TBUT) < 10 seconds, or
- Ocular surface staining graded between stages 1 and 3 according to the Oxford scale.
- Best-corrected visual acuity of 20/200 or better in both eyes.
- Able to provide written informed consent and comply with study procedures and scheduled visits.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Participation in another clinical trial or prior participation in the present study.
- Best-corrected visual acuity worse than 20/200 in either eye.
- Active ocular disease including conjunctivitis, blepharitis, keratitis, ocular trauma, ocular surface scarring, corneal ulcers, neurotrophic keratitis, bullous keratopathy, or neoplastic disease of the ocular surface.
- Glaucoma or eyelid disorders that affect normal eyelid function.
- Advanced dry eye disease requiring second-line TFOS DEWS II therapy.
- Ocular surgery within the previous 3 months.
- Contact lens use within 15 days prior to enrollment.
- Known hypersensitivity to any component of the study medications.
- Substance dependence within the previous 2 years.
- Systemic conditions that could increase the risk of study participation or interfere with interpretation of study outcomes, as judged by the investigators.
- Women of childbearing potential not using stable contraceptive methods for at least 30 days prior to enrollment and throughout the study duration.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Systane Complete twice daily
Participants in this arm will instill one to two drops of Systane Complete in each eye twice daily for 30 days.
They will be instructed to maintain a minimum interval of eight hours between doses and to avoid using additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
|
Systane Complete is a commercially available lipid-containing artificial tear formulation that combines mineral oils with nano-droplet lipid technology to support all three layers of the tear film (lipid, aqueous, and mucin).
In this study, participants assigned to this intervention will instill one to two drops in each eye twice daily for 30 days, maintaining a minimum interval of eight hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
其他名称：
|
|
有源比较器：Thealoz Duo four times daily
Participants in this arm will instill one to two drops of Thealoz Duo in each eye four times daily for 30 days.
They will be instructed to maintain a minimum interval of four hours between doses and to avoid using additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
|
Thealoz Duo is a commercially available ophthalmic solution that combines hyaluronic acid with trehalose to protect the ocular surface and support epithelial recovery in dry eye disease.
In this study, participants assigned to this intervention will instill one to two drops in each eye four times daily for 30 days, maintaining a minimum interval of four hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
大体时间：From baseline (day 0) to day 30 of treatment
|
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire that measures the frequency of dry eye symptoms and their impact on visual function and daily activities.
Scores range from 0 to 100, with higher scores indicating more severe symptoms.
In this trial, participants complete the OSDI at baseline and after 30 days of treatment.
The primary outcome is the adjusted mean OSDI score at day 30, analyzed using analysis of covariance (ANCOVA) with baseline OSDI as a covariate to compare twice-daily Systane Complete with four-times-daily Thealoz Duo within a non-inferiority framework.
|
From baseline (day 0) to day 30 of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in tear break-up time (TBUT) from baseline to day 30
大体时间：Baseline and day 30 after start of treatment
|
Tear break-up time (TBUT) is measured using fluorescein dye as the interval in seconds between a complete blink and the first appearance of a discontinuity in the tear film.
TBUT is assessed in both eyes at baseline and at day 30 under controlled environmental conditions; values from the right and left eyes are averaged to obtain a single patient-level value.
The secondary outcome is the change in mean TBUT (seconds) from baseline to day 30 and the between-group comparison of TBUT at day 30.
|
Baseline and day 30 after start of treatment
|
|
Change in Schirmer test value from baseline to day 30
大体时间：Baseline and day 30 after start of treatment
|
Schirmer test without anesthesia is used to assess tear production by placing filter paper strips in the lower eyelid for 5 minutes and measuring the length of wetting in millimeters.
Schirmer test is performed in both eyes at baseline and at day 30; measurements from right and left eyes are averaged to generate a single patient-level value.
The secondary outcome is the change in mean Schirmer test value (millimeters) from baseline to day 30 and the between-group comparison of Schirmer values at day 30.
|
Baseline and day 30 after start of treatment
|
|
Treatment adherence over 30 days of follow-up
大体时间：Day 15 and day 30 of treatment
|
Treatment adherence is evaluated using patient-completed daily treatment diaries that record each administration of the assigned study medication.
Adherence (%) is calculated using the formula AD = (RA × 100) / IA, where RA is the number of recorded administrations and IA is the total number of indicated applications according to the prescribed dosing regimen.
Adherence is assessed at day 15 and day 30.
Participants with adherence values below 90% are considered to have protocol deviations and are excluded from the per-protocol analysis.
|
Day 15 and day 30 of treatment
|
|
Change in Oxford corneal and conjunctival staining score from baseline to day 30
大体时间：Baseline and day 30 after start of treatment
|
Corneal and conjunctival epithelial staining is evaluated using fluorescein and graded according to the Oxford grading scale for ocular surface staining.
The Oxford scale ranges from grade 0 (no staining) to grade 5 (severe staining), with higher grades indicating more extensive epithelial damage.
Staining is assessed in both eyes at baseline and at day 30; scores from the right and left eyes are averaged to obtain a single patient-level value.
The secondary outcome includes the change in mean Oxford staining score from baseline to day 30 and the proportion of participants achieving complete resolution of corneal staining (Oxford grade 0) at day 30 in each treatment group.
|
Baseline and day 30 after start of treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Dalia Denisse Ng-Aleman, MD、Hospital Puerta de Hierro
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年1月6日
初级完成 (实际的)
2025年6月30日
研究完成 (实际的)
2025年6月30日
研究注册日期
首次提交
2026年7月19日
首先提交符合 QC 标准的
2026年7月19日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- HPH-DED-SYS-2026-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The datasets generated and analysed during the current study are not publicly available due to institutional and patient privacy restrictions, but are available from the corresponding author on reasonable request.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Systane Complete的临床试验
-
Scripps Poway Eyecare and OptometrySengi完全的
-
NovoNatum Ltd招聘中
-
Anaiah Healthcare Pvt LtdThe Leeds Teaching Hospitals NHS Trust; Brighton and Sussex University Hospitals NHS Trust; Great...未知