NCT02028312撤回4 期
A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®
Edward Holland, MD1 个研究点 分布在 1 个国家开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Fluorescein corneal staining scores
研究概览
简要总结
A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- •Are between the ages of 21 and 80 inclusive.
- •Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.
- •Have been on stable oral medications for 1 month prior to the study.
- •Are in generally good and stable overall health.
- •Are a woman of child bearing potential (WOCBP) who is not pregnant or lactating and not sexually active (i.e. abstinent) at Visit 1 and willing to remain so through Visit
- •Alternatively, a WOCBP who is not abstinent must have been using an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study.
- •Are women who have undergone one of the following sterilization procedures at least 1 month prior to Visit 1:
- •Bilateral tubal ligation
- •Hysterectomy
- •Hysterectomy with unilateral or bilateral oophorectomy.
- •Bilateral oophorectomy
- •Are likely to comply with the eye drop regime, study guidelines, and study visits.
排除标准
- •Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
- •Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
- •Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
- •Have a history of liver disease.
- •Be pregnant or lactating.
- •Have severe clinical vitamin deficiencies or a history of vitamin overdose.
- •Have a highly variable vitamin intake.
- •Wear contact lenses.
- •Have unstable use of systemic or topical medications known to create dry eye.
- •Have corneal pathology, which could, of itself, cause an ocular surface disorder.
- •Have used glaucoma medications, topical or oral within 30 days of Visit 1/Screening and Baseline Visit.
- •Have unstable diabetes mellitus.
- •Have an allergy or sensitivity to Lotemax® Gel, Restasis®, or non-preservative artificial tears.
- •Have used topical steroids or Restasis® within 1 month prior to the Screening and Baseline Visit and throughout the study, except the study medication provided per the protocol.
- •Have a condition for which steroid use would be contraindicated (e.g. viral infection).
- •Use other topical ocular agents other than tear replacements within 1 week prior to the Screening and Baseline Visit and throughout the study.
- •Have been exposed to an investigational drug within the preceding 30 days.
- •In the opinion of the investigator or study coordinator, be unwilling or unable to comply with the study protocol or unable to successfully instill eye drops.
研究组 & 干预措施
Loteprednol etabonate + Restasis
Active Comparator
Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days
干预措施: Restasis (Drug)
Loteprednol etabonate + Restasis
Active Comparator
Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days
干预措施: Loteprednol etabonate (Drug)
Artificial Tears + Restasis
Placebo Comparator
Artificial Tears, BID 30 days Restasis, BID 45 days
干预措施: Artificial Tears (Drug)
Artificial Tears + Restasis
Placebo Comparator
Artificial Tears, BID 30 days Restasis, BID 45 days
干预措施: Restasis (Drug)
结局指标
主要结局
Fluorescein corneal staining scores
时间窗: 60 Days
次要结局
- Lissamine green conjunctival staining(60 Days)
研究者
Edward Holland, MD
Sponsor-Investigator
Holprovision
研究点 (1)
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