Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Horus Pharma
- 入组人数
- 80
- 主要终点
- Demonstrate the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
研究概览
简要总结
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
详细描述
Evaluation of the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between D0 and D35.
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Comparison of D35 versus D0 and D84 versus D0 for each product and comparison between products for the following parameters:
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Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
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Evolution of OSDI score (Ocular Surface Disease Index).
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Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye.
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Evolution of Schirmer test result in worse eye.
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Evolution of Tear film Break-Up Time (TBUT) in worse eye.
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Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms
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Evaluation of treatment performance by the investigator and the patient.
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Evaluation of the average frequency of use during 84 days for DM05 and OptiveTM.
Selection visit: D-14 to D-7
Wash-out period: 1 to 2 weeks with preservative-free 0.9% NaCl at 3 drops per day (Hydrabak®):
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 (Investigator)
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
- •Sex: male or female.
- •Age: more than 18 years.
- •Subject with a dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
- •Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 or 2 weeks before inclusion (at 3 drops per day).
- •Diagnosis of moderate to severe ocular dryness defined by a score OSDI (Ocular Surface Disease Index) ≥
- •Subject with at least one eye with:
- •Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 (Oxford scale from 0 to 15)
- •AND one the following criteria:
- •Schirmer test ≥ 3mm/5 min and ≤9mm/ 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 protocol, at the Investigator's appreciation.
- •In France: 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
- •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 sanitary establishment.
- •Major subject who is under guardianship or who is not able to express his 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.
- •Far best corrected visual acuity < 1/10
- •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)
- •Within the last 3 months prior to the inclusion, history of ocular trauma, infection or inflammation not related to dry eye syndrome.
- •Within the last 12 months, history of ocular allergy or ocular herpes.
- •Refractive or cataract surgery within the last 6 months.
- •Any laser other than refractive surgery within the last 3 months.
- •Any troubles of the ocular surface not related to dry eye syndrome.
- •Ocular hypertension or glaucoma needing an hypotonic treatment
- •Subject having used artificial tears in the 6 hours preceding the inclusion visit.
- •Use during the month preceding the inclusion or during the study of: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs.
- •Any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.
研究组 & 干预措施
the investigational device: DM05
DM05 eye drops, multidose sterile emulsion, will be administered in the DM05 Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days
干预措施: DM05 eye drops (Device)
The comparative device : Optive™
Optive™ eye drops, multidose sterile solution, will be administered in the Optive Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days
干预措施: Optive™ eye drops (Device)
结局指标
主要结局
Demonstrate the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
时间窗: 35 days
Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
次要结局
- To assess the total ocular surface fluorescein staining score at D84(0 and 84 days)
- Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)(84 days)
- Global treatment performance score assessed by the investigator at visit 4(84 days)
- Global treatment performance score assessed by the patient at visit 3(35 days)
- Evolution of DEQ-5 score(84 days)
- Evolution of Tear film Break-Up Time(84 days)
- Global treatment performance score assessed by the investigator at visit 3(35 days)
- Volume tear fluid secretion as assessed by schirmer test(84 days)
- Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)(35 days)
- Evolution of Van Bijterveld score ( lissamine green staining)(84 days)
- Global treatment performance score assessed by the patient at visit 4(84 days)