NCT06245421已完成不适用
Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of DM934 Versus Théalose on the 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
- 85
- 试验地点
- 6
- 主要终点
- Cornea and conjunctiva staining (Oxford score)
研究概览
简要总结
This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of DM934 in comparison with Théalose in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment
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 (Outcomes Assessor)
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 needing artificial tears in the 3 months preceding the inclusion.
- •Subject having used only artificial tears without preservative (NaCl 0.9%, Larmabak®) during 1 to 2 weeks before inclusion (up to 6 times a day) (given during wash-out period).
- •Subject with a score ≥ 18 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.
- •For applicable countries: 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.
排除标准
- •Far best corrected visual acuity < 1/10 (according to Snellen Chart)
- •Subject with severe ocular dryness with one of these conditions:
- •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 .
- •Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
- •Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs 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 stabilised 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 deprived of freedom by administrative or legal decision.
- •Subject in a social or health institution.
- •Subject who is under guardianship or who is not able to express his/her consent.
- •Subject being in an exclusion period for a previous study.
- •Subject suspected to be non-compliant according to the Investigator's judgment.
- •Subject wearing contact lenses during the study.
结局指标
主要结局
Cornea and conjunctiva staining (Oxford score)
时间窗: 35 days
Evaluation of the non-inferiority of DM934 in comparison with Théalose, in terms of cornea and conjunctiva staining (Oxford score), on worse eye
次要结局
- Cornea and conjunctiva staining (Oxford score) (performance)(84 days)
- OSDI (questionnaire)(performance)(84 days)
- Van Bijsterveld score (performance)(84 days)
- Schirmer test (performance)(84 days)
- Global performance by the investigator (performance)(84 days)
- Global performance by the patient (performance)(84 days)
- Number of Adverse Events (safety)(84 days)
- Tear-Film Break Up Time (TBUT) (performance)(84 days)
- Dry eye symptoms (performance)(84 days)
研究者
研究点 (6)
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