NCT05723770已完成4 期
Effects of NOV03 on the Tear Film in Subjects With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Thickness of the Mucus-aqueous Tear Film Layer
研究概览
简要总结
Determine the effect of a single instillation of NOV03 on the thickness and evaporation rate of the mucus-aqueous layer of the tear film
详细描述
Characterize the effect of a single instillation of NOV03 on the lipid layer of the tear film
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •General/Ocular Inclusion Criteria
- •Will be at least 18 years of age at the time of consent.
- •Able to provide written voluntary informed consent.
- •Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit
- •Have Tear film break-up time (TFBUT) ≤5 sec at Visit
- •Have Ocular Surface Disease Index (OSDI) ≥25 at Visit
- •Have an unanesthetized Schirmer's Test I ≥5 mm at Visit
- •Have Meibomian Gland Dysfunction (MGD) defined as total MGD score ≥ 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit
- •Have a total corneal fluorescein staining score of ≥2 and ≤11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit
- •Have at least one eye that satisfies all criteria for 4-8 above at Visit
- •Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus
- •Is able and willing to follow instructions, including participation in all trial assessments and visits.
排除标准
- •General/Ocular Exclusion Criteria
- •Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit 2 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including
- •history of eye trauma
- •history of Stevens-Johnson syndrome
- •active blepharitis or lid margin inflammation
- •DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency).
- •abnormal lid anatomy that caused incomplete eyelid closure
- •abnormal cornea shape (keratoconus)
- •corneal epithelial defect or significant confluent staining or filaments
- •history of herpetic keratitis.
- •has a pterygium in either eye.
- •ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial
- •Has used any topical ocular steroids treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication within 60 days prior to Visit
- •Have had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit
- •Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit
- •Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit
- •Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
- •Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial.
- •Have undergone intraocular surgery or ocular laser surgery within the previous 6 months or had any planned ocular and/or lid surgeries over the trial period.
- •Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics.
- •Is a woman who was pregnant, nursing or planning a pregnancy.
- •Is a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception included: hormonal (oral, implantable, injectable, or transdermal contraceptives); mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom); intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence could have been regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
- •Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial.
- •Has a known allergy and/or sensitivity to the investigational drug.
- •Has used any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial.
- •Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit
- •Has corrected VA worse than or equal to logarithm of the minimum angle of resolution (LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts in both eyes at Visit
- •Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.
研究组 & 干预措施
Perfluorohexyloctane
Experimental
干预措施: instillation of NOV03 (Drug)
结局指标
主要结局
Thickness of the Mucus-aqueous Tear Film Layer
时间窗: over 4 hours following instillation of NOV03
Thickness of the mucus-aqueous layer of the tear film, measured in nanometers
Thinning Rate of the Mucus-aqueous Tear Film Layer
时间窗: over 4 hours following instillation of NOV03
The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second
次要结局
未报告次要终点
研究者
研究点 (1)
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