Phase I-II Clinical Trial to Compare the Safety and Efficacy of Nanodrop® Against Systane® Balance in the Treatment of Dry Eye Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
Study design:
Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA), related to the research product, recruitment is continued until the sample is completed for efficacy analysis
objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (EA) related to the research product (PI).
Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface Disease Index (OSDI).
Hypothesis
Security:
H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of unexpected adverse events related to the research drug, less than 20% of the population of Nanodrop® safety group.
H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of unexpected adverse events related to the research drug, exceeding 20% of the population of Nanodrop® safety group.
Effectiveness:
H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score.
H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score.
Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes).
Main inclusion criteria: Dry eye diagnosis
Duration of intervention treatment: 28 days Approximate duration of the subject in the study: 35 days
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, Investigator)
盲法说明
Masking will be done through the primary and secondary packaging.
They will be identified by means of identical tags. Which, in compliance with current and applicable regulations, must contain at least:
- Name, address and telephone number of the sponsor.
- Pharmaceutical form and route of administration.
- Lot Number.
- Legend "Exclusively for clinical studies"
- Date of Expiry.
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
- •Have the ability to voluntarily grant your signed informed consent
- •Power and willingness to comply with scheduled visits treatment plan and other study procedures
- •Be willing to modify the activities of your lifestyle.
- •Be of legal age
- •Women of reproductive age should ensure continuation (initiated ≥ 30 days prior to the signing of the Informed Consent Form or ICF) of using a hormonal contraceptive method or intrauterine device (IUD) during the study period
- •Present a dry eye diagnosis, defined by:
- •OSDI ≥ 13 points plus one of the following:
- •Corneal staining with more than 5 sites
- •Conjunctival staining with more than 9 sites
- •Breakup Time of lacrimal film (BUT) <10 seconds:
排除标准
- •In the case of women: being pregnant, breastfeeding or planning to get pregnant within the study period.
- •Have participated in another clinical research study ≤ 30 days before the scrutiny visit.
- •Having previously participated in this study.
- •Present a Better Corrected Visual Acuity (MAVC) of 20/200 or worse in one of the eyes.
- •Present an added ophthalmological diagnosis of:
- •Allergic, viral or bacterial conjunctivitis. Anterior blepharitis. Demodex. Eye parasitic infections. Unresolved eye trauma. Healing diseases of the ocular surface. Corneal or conjunctival ulcers. Filamentous keratitis. Neurotrophic keratitis. Bullous keratopathy. Neoplastic diseases on the ocular surface or annexes. Diseases with fibrovascular proliferations on the conjunctival and / or corneal surface.
- •Diseases in the retina and / or posterior segment that require treatment or threaten the visual prognosis.
- •Have a management of your dry eye that requires the implementation of stage 2 treatments of the recommendations in the treatment and management by stages for the dry eye disease from the Dry Eye Workshop II of The Tear Film and Ocular Surface Society (DEWS II, TFOS).
- •Have a history of drug addiction or current drug dependence or within the last two years prior to the signing of the Informed Consent Form.
- •Have a history of ocular surgical procedure within the last 3 months prior to the signing of the Informed Consent Form.
- •Be a user of soft or hard contact lenses. You can enter if you can suspend your use during the study, you must turn 15 days without using the contact lens before inclusion.
- •Having another medical condition, acute or chronic, that at the discretion of the researcher could increase the risk associated with participation in the study or administration of the product under investigation, or that could interfere with the interpretation of the results of the study.
- •Present known hypersensitivity to the components of the products under investigation.
- •Be or have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is an employee of the research site or the sponsor, and who participates directly in this study.
研究组 & 干预措施
Nanodrop® (PRO-176)
- Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic.
干预措施: Nanodrop® (Drug)
Systane® Balance
- Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc.
- Route of administration: Ophthalmic.
干预措施: Systane Balance (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: will be evaluated at the end of the treatment (day 29, final visit)
OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale.. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.
Percentage of Unexpected Adverse Events (AE) Related to the Research Product
时间窗: during the 29 days of evaluation, including the safety call
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
次要结局
- Visual Acuity (VA)(will be evaluated at the end of the treatment (day 29, final visit))
- Epithelial Defects (ED) Fluorescein Stain(will be evaluated at the end of the treatment (day 29, final visit))
- Epithelial Defects (ED) Green Lissamine(will be evaluated at the end of the treatment (day 29, final visit))
- Incidence of Expected Adverse Events(will be evaluated at the end of the treatment (day 29, final visit))
- Tear Breakup Time (TBUT)(will be evaluated at the end of the treatment (day 29, final visit))