A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change over time of OSDI score
研究概览
简要总结
Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Although there isn't a simple cure for dry eye, there are numerous products on the market that attempt to help relieve some of the discomfort caused by this condition. Some of these products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications. The purpose of this study is to evaluate the performance of a combination of TheraTears® products, and to compare them with the product(s) you have been using.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is between 18 and 65 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Exhibits symptoms of dry eye for at least 3 months;
- •Has an OSDI score of ≥ 23;
- •Is currently on a non-omega 3 dry eye treatment regimen that, at the minimum consists of instilling artificial tears at least once a day for the past 3 months;
- •Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye.
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection and/or allergies;
- •* For the purposes of study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are typical findings and are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally;
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Has taken part in another (pharmaceutical) research study within the last 30 days;
- •Has worn contact lenses within the past 5 years;
- •Is currently using or have used omega 3 supplements in the past 3 months.
研究组 & 干预措施
Treatment
Participants in the study treatment group will receive all four products:
- TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD
- TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD
干预措施: TheraTears® Lubricant Eye Drop (Drug)
Treatment
Participants in the study treatment group will receive all four products:
- TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD
- TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD
干预措施: TheraTears® preservative-free single-use containers (Drug)
Treatment
Participants in the study treatment group will receive all four products:
- TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD
- TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD
干预措施: TheraTears® Nutrition (Dietary Supplement)
Treatment
Participants in the study treatment group will receive all four products:
- TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn
- TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD
- TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD
干预措施: TheraTears® TheraLid® Eyelid Cleanser (Other)
结局指标
主要结局
Change over time of OSDI score
时间窗: At screening, 2 weeks, 1 month and 3 months
Ocular Surface Disease Index (OSDI) questionnaire score
Change over time of Visual analogue scores
时间窗: At screening, 2 weeks, 1 month and 3 months
Change over time of Tear osmolarity
时间窗: At screening, 1 month and 3 months
Change over time of Tear film breakup time
时间窗: At screening, 1 month and 3 months
Change over time of Corneal staining
时间窗: At screening, 1 month and 3 months
次要结局
- Change over time of Lid wiper epitheliopathy(At screening, 1 month and 3 months)
- Change over time of Meibomian gland expressibility(At screening, 1 month and 3 months)
- Change over time of Meibum quality(At screening, 1 month and 3 months)
- Change over time of Tear film lipid layer thickness(At screening, 1 month and 3 months)
- Change over time of Tear meniscus height(At screening, 1 month and 3 months)
- Change over time of Schirmer's I scores(At screening, 1 month and 3 months)