NCT04911361已完成4 期
The DEPOT Study (Dry Eye Prescription Options for Therapy): A Randomized Controlled Clinical Trial Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Eyelid Canaliculus in Comparison to Topical Loteprednol Suspension for the Treatment of Episodic Dry Eye
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- To determine effect of dexamethasone insert
研究概览
简要总结
Assessing DEXTENZA efficacy and safety when placed within the lower eyelid canaliculus for dry eye flares in comparison to topical loteprednol suspension.
详细描述
The DEPOT Study (Dry Eye Prescription Options for Therapy): A randomized controlled clinical trial assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower eye eyelid canaliculus in comparison to topical loteprednol suspension for the treatment of episodic 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
- 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
- 是
入选标准
- •Patients 18 years and older
- •Patients willing to take an electronic survey about their tolerability of either study medication.
- •Patients with a recent exacerbation of dry eye characterized by ocular surface discomfort.
排除标准
- •Active, systemic or local disease condition other than DES that causes clinically significant ocular surface irritation that could interfere with the evaluation and treatment of dry eye.
- •Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
- •Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure)
- •Clinically significant ocular trauma.
- •Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
- •Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
- •Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
- •Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
- •Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
- •Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
- •Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
- •Participation in this trial in the same patient's fellow eye.
- •Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
研究组 & 干预措施
Topical loteprednol suspension in both eyes
Active Comparator
25 subjects will be randomized to receive treatment loteprednol etabonate 0.5% suspension QID for 2 weeks.
干预措施: Dexamethasone (Drug)
Lower eyelid canaliculi DEXTENZA insertion (study group)
Experimental
25 subjects will be randomized to receive treatment of OTX-DED
干预措施: Dexamethasone (Drug)
结局指标
主要结局
To determine effect of dexamethasone insert
时间窗: 2 Weeks
SPEED score at Baseline and Week 2
次要结局
- The difference in tear break up time (TBUT) before and after treatment(4 Weeks)
- The difference in corneal staining before and after treament(4 Weeks)
- The difference in conjunctival hyperemia(4 weeks)
- To determine the effect of dexamethasone insert(4 Weeks)
研究者
研究点 (3)
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