A Randomized, Active-controlled, Parallel, Double-blind Study on the Safety, Ocular Tolerability and Efficacy of Piiloset Trehalose Emulsion Eye Drop in Adult Patients With Moderate or Severe Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change From Baseline OSDI
研究概览
简要总结
The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe dry eye in adult patients. The investigative device is studied in comparison with control eye drops containing hyaluronic acid for up to 30 days.
详细描述
According to the current view on dry eye disease, tear film instability, tear film hyperosmolarity, and ocular surface inflammation and damage are identified as etiological factors. The first-line medicinal management options include ocular lubricants such as eye drops and sprays. Emulsion eye drops are a relatively recent entity among topical therapies with an intention to account for deficiencies in the outermost lipid layer of the tear film.
Piiloset Trehalose Emulsion Eye Drops was developed to target and restore the three main layers (mucin, aqueous, and lipid) of the tear film and to counteract the key etiological factors leading to dry eye. Hyaluronic acid and the oil component are intended to restore tear film instability, the hypo-osmolar composition and trehalose as an osmoprotectant are intended to protect the ocular epithelium against hyperosmolarity, and ocular surface inflammation and cellular damage are prevented by the cytoprotective and/or anti-oxidative action of hyaluronic acid, trehalose, and sacha inchi oil components. Additional water binding in the tear film is provided by hyaluronic acid, trehalose, and glycerol. Lubricating the ocular surface by high-molecular-weight hyaluronic acid will extend the precorneal retention time. Adjustments made to certain physical and chemical parameters in the formulation are anticipated to improve tear film spreading and adhesion. The optically clear o/w emulsion formulation is free of preservatives, materials of animal origin, phosphates, or alcohol. The combined action of the individual components is expected to produce clinically relevant mitigation of the signs and symptoms of dry eye.
The study comprises three Parts with scheduled visits on Day 1 (all Parts) and on end-of-study date (Parts 2 and 3) to the study centre. Each study subject will participate in no more than one Part of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.
- •Age between 18 and 80 years.
- •At least two the following conditions (A and B):
- •A. Symptomatic dry eye with OSDI score ≥
- •Tear film break-up time (TBUT) <10 seconds. OR B
- •Positive ocular (corneal and conjunctival) staining pattern
- •Body weight at least 45 kg.
- •Under stable topical and/or systemic therapy for at least 4 weeks before the study procedures and apparent ability and willingness to abstain from other therapies until completion of the study period.
- •Ability and willingness to self-administer eye drops.
- •Ability and willingness to understand and fill in the OSDI questionnaire.
- •Ability and willingness to comply with the study protocol and other study-related procedures.
排除标准
- •History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier.
- •Evidence of acute or chronic infection in the cornea or conjunctiva.
- •Diagnosis of Sjögren's syndrome.
- •Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day.
- •Current ocular allergy symptoms.
- •Known allergy to any constituent of the trehalose emulsion eye drops or control eye drops.
- •Currently pregnant, nursing or planning to become pregnant before completion of the study period.
- •Any other condition that may, in the Investigator's opinion, jeopardize the safety or availability of the subject or adherence to the study protocol or may interfere with the interpretation of the results and would thus make the subject inappropriate for entry in the study.
结局指标
主要结局
Change From Baseline OSDI
时间窗: From baseline to Day 30 (Part 3)
Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.
Change From Baseline TBUT
时间窗: From baseline to Day 30 (Part 3)
Tear film break-up time (TBUT) (s)
Change From Baseline Tear Osmolarity
时间窗: From baseline to Day 30 (Part 3)
Instrumental assay of tear fluid osmolarity (mOsm/L)
次要结局
- Change From Baseline Conjunctival (Nasal) Staining(From baseline to Day 30 (Part 3))
- Change From Baseline Blink Rate(From baseline to Day 30 (Part 3))
- Change From Baseline Ocular Protection Index (OPI)(From baseline to Day 30 (Part 3))
- Change From Baseline Conjunctival (Temporal) Staining(From baseline to Day 30 (Part 3))
- Change From Baseline Corneal Staining(From baseline to Day 30 (Part 3))
研究者
Kai Kaarniranta
MD, PhD, Professor
Kuopio University Hospital