NCT06607237已完成不适用
Prospective, Single Arm, Open-label Clinical Investigation on the Evaluation of Safety and Efficacy of DM-28 for Treatment of Moderate to Severe Ocular Dryness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Horus Pharma
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Incidence of adverse device effects
研究概览
简要总结
This study is a pilot, exploratory study to check safety and efficacy of DM-28 device, a new medical device intended to treat moderate to severe ocular dryness.
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
- •Subject with a moderate to severe dry eye syndrome.
- •Subject with a score ≥ 23 for the OSDI (Ocular Surface Disease Index).
- •Subject with at least one eye with:
- •Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the Oxford scale (0 to 15)
- •AND one of the following criteria:
- •Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
- •Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.
- •Subject, having given freely and expressly his/her informed consent.
- •Subject who is able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation (investigator expertise).
- •Subject being affiliated to a health social security system.
- •Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end (subject declaration).
排除标准
- •Far best corrected visual acuity (FBCVA) < 1/10 (according to Snellen Chart)
- •Subject with severe ocular dryness with one of these conditions (investigator expertise):
- •Eyelid or blinking malfunction
- •Corneal disorders not related to dry eye syndrome
- •Ocular metaplasia
- •Filamentous keratitis
- •Corneal neovascularization
- •Subject with severe meibomian gland dysfunction (MGD)
- •History of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion
- •History of ocular allergy or ocular herpes within the last 12 months.
- •Any troubles of the ocular surface not related to dry eye syndrome.
- •Subject with hypersensitivity to one of the components of the investigational device.
- •Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
- •Use of the following systemic or ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs, corticoids or dry eye therapy (intense pulse light, stem cells) during the month preceding the inclusion.
- •Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study.
- •Any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.
- •Pregnant or nursing woman or planning a pregnancy during the study (subject declaration/ pregnancy test).
- •Subject deprived of freedom by administrative or legal decision (subject declaration).
- •Subject in a social or health institution (subject declaration).
- •Subject who is under guardianship or who is not able to express his/her consent (subject declaration/ investigator expertise).
- •Subject being in an exclusion period for a previous study (subject declaration).
- •Subject suspected to be non-compliant according to the Investigator's judgment (investigator expertise).
- •Subject wearing contact lenses during the study
结局指标
主要结局
Incidence of adverse device effects
时间窗: Day 35
Adverse device effects will be evaluated via ocular examination and ocular symptoms after instillation reported by the subjects
Cornea and conjunctiva staining (Oxford scale) (performance)
时间窗: Day 35
Main change from baseline of cornea and conjunctiva staining (Oxford scale form 0 to 15, 15 meaning a worse outcome) in the worse eye
次要结局
- Far best corrected visual acuity (FBCVA)(Day 35)
- General safety(Day 35)
- Cornea and conjunctiva staining (Oxford scale)(Day 35)
- OSDI (questionnaire)(Day 35)
- Schirmer test(Day 35)
- Tear-Film Break Up Time (TBUT)(Day 35)
- Conjunctival hyperaemia(Day 35)
- Global performance by the investigator(Day 35)
- Global performance by the patient(Day 35)
- Comfort upon device administration(Day 4, Day 11, Day 18, Day 25, Day 32)
- Patient satisfaction on device performance(Day 0, Day 7, Day 14, Day 21, Day 28, Day 35)
研究者
研究点 (2)
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