A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Azasite on Corneal Surface Irregularity in Subjects With Meibomian Gland Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in Corneal Irregularity Measurement
研究概览
简要总结
The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).
详细描述
This will be a single-center, randomized, vehicle-controlled, double-masked, clinical trial comparing a four week course of Azasite (azithromycin ophthalmic 1%) to vehicle (Durasite®) in patients with MGD-related evaporative dry eye. All patients will be evaluated at screening, baseline, two weeks, four weeks, and six weeks.
The primary outcome measure will be improvement, as compared to baseline, in corneal irregularity as measured by a topographically-derived value, the Corneal Irregularity Measurement (CIM). Secondary outcome measures will be a global symptom score, tear film break up time, meibomian gland secretion characteristics, best-corrected distance visual acuity, corneal staining, axial topography based astigmatism patterns, and IOL Master keratometry.
We will enroll 60 eyes of 30 patients, and each patient will be randomly assigned to receive Azasite in one eye and vehicle (Durasite®) in the fellow eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent prior to enrollment in study
- •Patient ability to follow study instructions and comply with all study protocols
- •Corneal irregularity measurement (CIM) > 1.7 in both eyes
- •Non-atrophic meibomian gland dysfunction (MGD) as defined by abnormal meibomian expression in at least 2 meibomian glands of the eyelids of each eye
- •At least two symptoms of at least moderate severity (≥ grade 2, 0 to 3 scale) as defined in the MGD Global Symptom Score (Itching, Foreign-body sensation, Dryness, Burning, Lid swelling)
- •Tear film break up time < 10 seconds
- •Schirmer with anesthesia > 5 mm
- •Best corrected distance visual acuity (BCDVA) > 20/100
排除标准
- •Cicatricial or atrophic meibomian gland dysfunction (MGD)
- •Any corneal disease or scar involving the central 6 mm, including epithelial basement membrane dystrophy, Salzmann nodular degeneration, recurrent erosions, keratoconus or ectasia
- •Use of azithromycin or doxycycline within 1 month of screening
- •Topical ocular antibiotic, anti-histamines, allergy, or steroid medication within 2 weeks of baseline (a 2 week washout after screening will be allowed)
- •Topical prostaglandin analogue use within 30 days of study
- •The anticipated use of any drops, gels or ointments during the study period outside of the study protocol
- •Use of eye make-up during study period
- •Active ocular infection or inflammation
- •History of herpetic eye disease or neurotrophic keratitis
- •Lid pathology (except MGD or blepharitis) that the examiner feels may affect the ocular surface
- •Significant conjunctival scars (ex. h/o SJS)
- •Pterygium
- •Lacrimal punctal occlusion within 2 months of screening
- •Ocular surgery within 1 year of screening
- •Monocular patients
- •Pregnant, breast-feeding, or sexually active females not using contraception
- •Uncontrolled systemic disease
- •Presence of any disease (medical or ocular) that, in the opinion of the investigator, may interfere with the study's safety or interpretation
- •Known allergy to the study medication or its components
- •Current enrollment in an investigational drug or device study within 30 days of screening for this study
研究组 & 干预措施
Treatment eye
Azasite (azithromycin ophthalmic 1%) twice a day for 2 days followed by nightly for 4 weeks
干预措施: Azasite (Drug)
Durasite
Vehicle of Azasite used as placebo
干预措施: Azasite (Drug)
结局指标
主要结局
Change in Corneal Irregularity Measurement
时间窗: 4 weeks
Topographically defined corneal smoothness as compared to baseline measurement at day 0
次要结局
- Meibomian gland secretion characteristics(2, 4 and 6 weeks)
- Intraocular Lens(IOL) Master Keratometry(2, 4 and 6 weeks)
- Global symptoms score(2,4 and 6 weeks)
- Best corrected distance visual acuity(2, 4 and 6 weeks)
- Corneal staining(2, 4 and 6 weeks)
- Axial topography based astigmatism pattern(2, 4 and 6 weeks)
- Change in Corneal Irregularity Measurement(2 weeks, 6 weeks)