Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease: A Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label design due to differences in commercial presentation and dosing frequency of the study medications.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Systane Complete (Drug)
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.
干预措施: Thealoz Duo (Drug)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
时间窗: 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.
次要结局
- Change in tear break-up time (TBUT) from baseline to day 30(Baseline and day 30 after start of treatment)
- Change in Schirmer test value from baseline to day 30(Baseline and day 30 after start of treatment)
- Treatment adherence over 30 days of follow-up(Day 15 and day 30 of treatment)
- Change in Oxford corneal and conjunctival staining score from baseline to day 30(Baseline and day 30 after start of treatment)
研究者
Jose Navarro Partida
Ophthalmologist and Principal Investigator
Instituto Internacional de Medicina y Terapia (IIMET)