ACTRN12624000175572招募中Unknown
Prospective, randomised, parallel group, bilateral treatment trial to demonstrate the feasibility of the Meiboleyes prototype electronic heating device when compared to the BRUDER Moist heat Eye Compress in patients with meibomian gland dysfunction.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
- •Be at least 18 years old.
- •Willing to comply with the clinical trial as directed by the Investigator.
- •Best-corrected visual acuity of 20/40 or better in each eye at the baseline visit
- •Evidence of meibomian gland obstruction (based on a meibomian gland secretion score of less than or equal to 12 for 15 glands of the lower lid) in both eyes at the baseline visit.
- •Evidence of active MGD associated signs and symptoms at the baseline visit:
- •oOSDI questionnaire score more than or equal to 13
- •oFluorescein TBUT < 10 seconds in both eyes
排除标准
- •Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca associated with MGD) or uncontrolled systemic disease;
- •Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity;
- •Ocular hypertension or diagnosed glaucoma;
- •Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye at any time or anticipate such a procedure during the study;
- •LipiFlow® or other professional in-office lid-heating therapy, meibomian gland probing, or therapeutic gland expression in either eye within 6 months prior to baseline;
- •MGD treatments including warm compress therapy, eyelid hygiene, eyelid massage, and manual lid expression within 2 weeks prior to baseline;
- •Corneal, conjunctival, or eyelid inflammation (including allergic, vernal, or giant papillary conjunctivitis and mucous membrane pemphigoid) that in the judgment of the investigator may interfere with the study results or the ability of subjects to complete the treatment period;
- •Contact lens use anticipated during the study;
- •Planned anterior segment surgery (e.g., cataract surgery or any surgery involving a limbal or corneal incision) in either eye during the study period;
- •Meibography score at the screening visit of 4 (greater than 75% partial glands using the gestalt grading system);
- •Known allergy to spandex or silicone;
- •Pregnancy (verbal self-report) or breastfeeding;
- •Participation in another clinical trial involving a therapeutic drug or device within the past 30 days.
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