A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Sodium Chloride Eye Drops (0.5%) (Chamomile extract plus Euphrasia extract)
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- extract) (eye drop with herbal extract) by performing a set of eye examinations.
研究概览
简要总结
A post market clinical follow up prospective study to evaluate safety andperformance of Eye Preparations (Sodium Chloride Eye Drops (0.5%) (Chamomile extract +Euphrasia extract)
Sodium Chloride EyeDrops (0.5%) (Chamomile extract + Euphrasia extract)are used to relieve eye discomfort and soreness due toenvironmental factors Polyhexamethylene biguanide binds to thenegatively charged phospholipids found in the microbial plasma membranescausing membrane disruption and cellular lysis. Disodium edetate is a cationicchelating agent that binds free metals and enhances antimicrobial activity ofdisinfectants. Chamomile extract used to treat eye inflammation and infectionand reported for its antibacterial, anti-inflammatory, astringent properties.Cooled chamomile infusion can be used for soothe, tired, irritated eyes. Euphrasiahas antimicrobial effect. Helps treating the eyes. Euphrasia is used in eyebaths and eye drops, for watery, reddened and irritated eyes, for swolleneyelids, for sticky eyes in the morning and against tired, overstrained eyes. BoricAcid to create a stable balance that resists changes in the solution’s pH. Sodiumchloride is an Electrolyte added to maintain osmolarity as high osmolarityproducts pull water from epithelial cells. Sodium Chloride Eye Drop (0. 5%) (Chamomile extract + Euphrasiaextract) can be used to protect the eye from irritations/dryness/discomfort dueto continuous use of computer/TV/exposed pollution/dry environment and use ofcontact lenses
There will be 4 follow up visits expected after using theproduct:
1st Visit - After 8 days of using the product
2nd Visit- After one month of using the product
3rd Visit- After two months of using the product
4th Visit - After three months of using the product
| Intended purpose |
Persons who experience Irritation, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment use the eye drop with herbal extract to soothe the eyes.
|Intended users
Persons who experience Irritation /itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment.
This study will be a prospective, multi-centric, non-randomized study.The subjects visiting the study centers with the complaints such as eyedryness, Itchiness, discomfort of eyes due to the continuous use ofcomputer/TV/exposed pollution/dry environment will be screened at Day 0 and ifthey meet the inclusion and exclusion criteria, then they will be selected forthe study. A total of 54 subjects will berecruited for this study for the Sodium Chloride Eye Drops (0.5%) (Chamomileextract + Euphrasia extract).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •At the time of screening and usage of the product all subjects must meet the following criteria for inclusion into the study and the subjects will receive the prescribed eye drops with herbal extract from the PI/CO-I by a medical practitioner.
- •The inclusion criteria for the subjects for this study are as follows: -Subjects who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment -Subjects wearing contact lenses who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment.
排除标准
- •The below Subjects are excluded from the study: -Subjects who are not willing to participate in the study -Anyone with known allergic reaction to Sodium Chloride Eye Drops (0.5%) (Chamomile extract + Euphrasia extract) -Subjects with existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye medication.
结局指标
主要结局
extract) (eye drop with herbal extract) by performing a set of eye examinations.
时间窗: 1st Visit - After 8 days of using the product | 2nd Visit - After one month of using the product | 3rd Visit - After two months of using the product | 4th Visit - After three months of using the product.
The primary objective is to confirm clinical safety and performance of the
时间窗: 1st Visit - After 8 days of using the product | 2nd Visit - After one month of using the product | 3rd Visit - After two months of using the product | 4th Visit - After three months of using the product.
product Sodium Chloride Eye Drop (0. 5%) (Chamomile extract + Euphrasia
时间窗: 1st Visit - After 8 days of using the product | 2nd Visit - After one month of using the product | 3rd Visit - After two months of using the product | 4th Visit - After three months of using the product.
次要结局
- The secondary objective is to assess any emerging undesirable events along with monitoring of desired events, contraindications, residual risk, emerging risk under normal usage of the eye drops with herbal extract for prolonged period to ensure acceptability of benefit risk ratio of the eye drop with herbal extract, which will be recorded in CRF during every follow up visit based on the subject rating. The study will be focused on identifying possible systematic misuse or off-label use of the device.(1st Visit - After 8 days of using the product)