SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
研究概览
简要总结
The purpose of this study was to assess the efficacy of the SYSTANE® family of products (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on meibomian gland functionality in subjects with lipid deficiency related to evaporative dry eye as compared to the standard of care warm compresses.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;
- •Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;
- •Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period;
- •Must have best corrected visual acuity of 20/40 Snellen or better in each eye;
- •Must be able to follow instructions and be willing and able to attend required study visits;
- •Must read, sign, and date an Ethics Committee reviewed and approved informed consent form;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months;
- •Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
- •History of intolerance or hypersensitivity to any component of the study medications;
- •History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
- •Pregnant or lactating at the time of enrollment;
- •Not willing to take adequate precautions not to become pregnant during the study;
- •Use of any concomitant topical ocular medications during the study period;
- •Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
- •Ocular conditions that may preclude the safe administration of either drop under investigation;
- •Unwilling to discontinue contact lens wear during the study period and for at least 1 week prior to Visit 1;
- •Participation in an investigational drug or device study within 30 days of entering this study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
SYSTANE® Family
SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
干预措施: SYSTANE® Lid Wipes (Other)
SYSTANE® Family
SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
干预措施: SYSTANE® BALANCE (Other)
SYSTANE® Family
SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
干预措施: SYSTANE® Vitamins (Dietary Supplement)
Standard of Care
Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
干预措施: Microfiber towels (as warm compresses, with or without saline eye drops) (Other)
结局指标
主要结局
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
时间窗: Baseline, Month 1, Month 2, Month 3
Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.
次要结局
- Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses(Baseline, Month 1, Month 2, Month 3)
- Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses(Baseline, Month 1, Month 2, Month 3)