A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tear Break up Time
研究概览
简要总结
The purpose of this research study is to evaluate the effectiveness and safety of applying androgen sex hormone (i.e., testosterone) gel on the eyelids in the treatment of dry eye patients. Several studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.
详细描述
The purpose of this study is to examine the safety and efficacy of transdermal eyelid application of testosterone gel along with the length of any beneficial effect following cessation of treatment.
Moderate to severe dry eye subjects will be enrolled into a randomized controlled trial with assignment to either an ~ 4.5% FDA-approved androgen gel (Natesto®, Acerus Pharmaceuticals, Mississagua, Canada) or a placebo formulated similar to Natesto® without testosterone. The gel will be applied to both eyelids in the morning and 12 hours later on both eyelids for a 30 day treatment period
Subjects will fulfil DEWS II criteria for eligibility and further be classified as moderate or severe based on DEWS II recommendations. A standardized examination involving signs and symptoms of dry eye and monitoring function of the meibomian and lacrimal glands, as well as clinical tear and ocular surface measures, IOP, and serum testosterone levels, at baseline, following 30 days of testosterone application, and at one and two months post-treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double
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
- •Moderate to severe dry eye (TBUT < 6.0 seconds, corneal staining > grade 1.5, evidence of meibomian gland secretion compromise or Schirmer < 5 mm wetting in 5 minutes)
- •Age over 18
- •Mild ectropion
- •Previous contact lens wearers IF no wear for prior 6 months
- •Punctal plugs if more than three months since placement
- •Systemic tetracyclines, antihistamines if consistent dosing
- •Sjogren's syndrome and related autoimmune conditions can be enrolled
- •Patients using topical dry eye treatments (e.g., Restasis) if willing to discontinue for 30 days
排除标准
- •If artificial tears or autologous serum used on day of study
- •Ocular surgery if less than 12 months
- •Punctal plugs if within 3 months of plug insertion
- •Contact Lens wear within the six months prior to study
- •PSA levels greater than 4 ng/ml or BPH
- •Recent or current thrombolism
- •Recent or current cardiovascular events (e.g., MI, stroke)
- •Recent or current liver disorders
- •Concurrent use of topical medications; e,g., topical glaucoma medications
- •Diabetics
- •Females of child-bearing age if not on reliable birth control
- •History of breast cancer
- •Cannot be taking insulin, warfarin or systemic corticosteroids
研究组 & 干预措施
Vehicle Gel
Vehicle gel applied to eyelids twice per day
干预措施: Vehicle gel (Drug)
Testosterone gel 4.5%
Testosterone gel 4.5% applied to eyelids twice per day
干预措施: Testosterone gel 4.5% (Drug)
结局指标
主要结局
Tear Break up Time
时间窗: From baseline to 4 weeks treatment
Time to first dark spot appearance in the tear film
次要结局
- Lower Meibomian Gland Secretion Score (0 - 32 Scale)(From baseline to 4 weeks treatment)
研究者
Jerry Paugh
Professor
Southern California College of Optometry at Marshall B. Ketchum University