Pilot Study for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye in Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Mean Change in Meibomian Gland Score From Baseline at 3 Months
研究概览
简要总结
The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.
详细描述
This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).
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
- None
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
- •Diagnosis of meibomian gland dysfunction and dry eye
- •At least 18 years of age
- •Willing to comply with randomization, attend all study visits and follow patient instructions
- •Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
- •No change in contact lens type or dimensions for the past 3 months
- •Clinician assessment of acceptable contact lens fit and disinfecting solution
- •Tear film interferometry of 100 units or less
排除标准
- •Systemic disease conditions that cause dry eye
- •Use of systemic medications known to cause dryness
- •History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
- •Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
- •Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
- •Participation in another ophthalmic drug or device trial in the past month
- •Employee, relative of employee or associate of the clinical site
研究组 & 干预措施
LipiFlow
Single 12-minute LipiFlow treatment
干预措施: LipiFlow treatment (Device)
Untreated Control
Untreated Control (No Intervention)
Crossover LipiFlow Treatment
Crossover LipiFlow treatment of the untreated control group after 3 months
干预措施: LipiFlow treatment (Device)
结局指标
主要结局
Mean Change in Meibomian Gland Score From Baseline at 3 Months
时间窗: 3 Months
The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
次要结局
- Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months(3 Months)