NCT05514041已完成4 期
A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray
Stephenson Eye Associates2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Surface qualifier image change
研究概览
简要总结
A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray.
详细描述
A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Change in Cassini surface qualifier image analysis from baseline (pre-administration) to post-administration of OC-01 (varenicline solution) nasal spray as measured by a masked evaluator
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must:
- •Provide signed written consent prior to study-related procedures
- •Be at least 22 years of age at the screening visit
- •Be literate and able to complete questionnaires independently
- •Be able and willing to use the study drug and participate in all study assessments and visits
- •Have sufficient hand strength, in the opinion of the Investigator, to be able to independently administer the study drug
- •Have provided verbal and written informed consent
- •Have an Ocular surface disease index (OSDI) score ≥13,
- •Demonstrate corneal fluorescein staining (CFS) score of 2 or more in at least 1 corneal region, or a sum of 4 or more for all corneal regions, based on the National Eye Institute/Industry Workshop Scale
- •Demonstrate abnormal Cassini surface qualifier image at screening visit (at the determination of the investigator)
排除标准
- •Subjects must not:
- •Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
- •Have evidence of clinically significant ocular trauma
- •Have active ocular Herpes simplex or Herpes Zoster infection
- •Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
- •Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
- •Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- •Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
- •Have an ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity)
- •Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
- •Have chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to clinically significant risk of increased bleeding
- •Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- •Have any untreated nasal infection at Visit 1
- •Have a history of vascularized nasal polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction
- •Have current concomitant use of a nicotinic acetylcholine receptor agonist [Nicoderm®, Nicorette®, Nicotrol NS® (nicotine), Tabex®, Desmoxan® (cytisine), and Chantix® (varenicline)] within the previous 30 days of Visit 1 and during the treatment period.
- •Have undergone mechanical treatment for meibomian gland dysfunction using thermal pulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight) therapy within 6 months prior to the Screening/Baseline Visit
- •Use topical prescription ophthalmic medications including cyclosporine and/or lifitegrast within 6 months prior to the Screening/Baseline Visit and during the treatment period
- •Use topical ophthalmic corticosteroid therapy within 6 weeks prior to the Screening/Baseline visit and during the treatment period
- •Use ophthalmic artificial tear drops within 2 hours prior to any of the study visits; any concurrent use of artificial tears should be continued at same frequency and with no change in brand during the treatment period
- •Use prescription or Over-the-counter (OTC) topical ophthalmic mast cell stabilizers or antihistamines within 3 days of the Screening/Baseline visit and during the treatment period (systemic agents permitted)
- •Have a known hypersensitivity to any of the procedural agents or study drug components
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening/Baseline visit and during the treatment period.
研究组 & 干预措施
OC-01 (varenicline solution) nasal spray 0.03 mg
Experimental
Subjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations
干预措施: Varenicline solution (Drug)
Placebo nasal spray (OC-01 Vehicle Nasal Spray)
Placebo Comparator
Subjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations
干预措施: Placebo nasal spray (OC-01 Vehicle Nasal Spray) (Drug)
结局指标
主要结局
Surface qualifier image change
时间窗: Day 1
Change from baseline in Cassini surface qualifier image analysis to post-administration of OC-01 (varenicline solution) nasal spray (@15 minutes) on Day 1
次要结局
- Tear osmolarity(Day 28)
- Change from baseline in surface qualifier image analysis(Day 28)
- Corneal fluorescein staining score(Day 28)
- EDS(Day 28)
- TBUT(Day 28)
- QoL(Day 21)
- VA(Day 28)
- IOP(Day 28)
研究者
研究点 (2)
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