Symptomology Changes With Systane PRO PF Versus Thealoz Duo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Difference Ocular Surface Disease Index (OSDI) Score between Baseline and 4 Weeks
研究概览
简要总结
Ocular dryness and discomfort are symptoms commonly associated with dry eye. Lubricating eye drops, also called artificial tears, are often used to moisten the eye and provide relief from these symptoms. There are currently several types of lubricating eye drops available, differing in their ingredients, consistency, and recommended frequency of application. The aim of this study is to compare the effectiveness of two lubricating eye drops that differ in their ingredients and recommended frequency of application. The goal is to see whether they perform the same or if one of them provides better relief for people with dry eye symptoms. One of the eye drops is commercially available in Canada, the other one is not commercially available in Canada and therefore considered an investigational eye drop. This eye drop is available in the United States of America. In this study, participants will use one drop twice per day and the other drop four times per day. Each product will be used for 4 weeks and all participants will use both products (one after the other). There will be a 2-week period of no drops between the two study products. Before starting each drop and after 4 weeks of drop use, we will assess the eyes of the participants and ask them how their eyes feel. Participants will also be asked to answer a series of questions regarding the drops. Participants will encounter procedures that they normally experience in an eye care setting. The results will help the funding company to better understand the performance of the products used in this study. It may also help eyecare practitioners in managing their patients with dry eye symptoms. The hypothesis is that the drop used twice a day will be non-inferior to the drop used 4 times per day for the change in dry eye symptoms (assessed with the Ocular Surface Disease Index questionnaire) after 4 weeks of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Are at least 18 years of age and have full legal capacity to volunteer;
- •Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form;
- •Are willing and able to attend all study visits as required per protocol;
- •Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration;
- •Have dry eye symptomatology as per Tear Film & Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition:
- •Have an Ocular Surface Disease Index (OSDI) score ≥13;
- •Have an absence of active* anterior segment disease;
- •Have not worn contact lenses for the previous 14 days before screening, and are willing to not wear contact lenses for the duration of the study;
- •Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results.
排除标准
- •Have taken part in an interventional clinical study within the previous 14 days before screening;
- •Are participating in any concurrent ocular or interventional clinical trial;
- •Have any active* ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops);
- •Started any systemic medication known to cause dry eye (e.g., anti-histamine, antidepressants, benzodiazepines, etc.) within 30 days before screening. Stable dosing for >30 days before screening is allowed, but changes (including commencing new) of dosing of such medication within the study period would lead to early exit from the study;
- •Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
- •Have biomicroscopy signs of grade 3 or more (Efron scale);
- •Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products;
- •Are pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Are a member of the Centre for Ocular Research & Education directly involved in this study (on the delegation log);
- •Are an employee of Alcon.
研究组 & 干预措施
Systane Pro PF/ Thealoz Duo
Use of Systane Pro PF for 4 weeks, followed by use of Thealoz Duo for 4 weeks
干预措施: 3% trehalose and 0.15% sodium hyaluronate (Device)
Thealoz Duo / Systane Pro PF
Use of Thealoz Duo for 4 weeks, followed by use of Systane Pro PF for 4 weeks
干预措施: Propylene glycol 0.6% (Drug)
Thealoz Duo / Systane Pro PF
Use of Thealoz Duo for 4 weeks, followed by use of Systane Pro PF for 4 weeks
干预措施: 3% trehalose and 0.15% sodium hyaluronate (Device)
Systane Pro PF/ Thealoz Duo
Use of Systane Pro PF for 4 weeks, followed by use of Thealoz Duo for 4 weeks
干预措施: Propylene glycol 0.6% (Drug)
结局指标
主要结局
Difference Ocular Surface Disease Index (OSDI) Score between Baseline and 4 Weeks
时间窗: From baseline (dispense) to 4 weeks of ocular lubricant use
Within-subject difference in OSDI scores between baseline and after 4 weeks of use with each drop
次要结局
未报告次要终点