A post market clinical follows up prospective study to evaluate safety and performance of Preservative Free Eye Preparations (Preservative Free Eye Drops with Calendula Extract plus Hamamelis Extract
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The primary objective is to confirm clinical safety and performance of the product Sodium Chloride (0.75%) Eye Drops (eye drop with herbal extract) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, Schirmers test considering the baseline from the initial visit and obtained during the follow up visits. If the end user is a contact lens wearer contact lens characteristics will also be measured at the end of the study
研究概览
简要总结
A post market clinical follows up prospective study to evaluate safety andperformance of Preservative Free Eye Preparations (Preservative Free Eye Dropswith Calendula Extract + Hamamelis Extract).
PreservativeFree Eye Drops with Calendula +Hamamelis extract are used to relieve eye discomfort and soreness due toenvironmental factors .Sodium chloride is an Electrolyte added tomaintain osmolarity as high osmolarity products pull water from epithelialcells. Disodium edetateis a cationic chelating agent that binds free metals and enhances antimicrobialactivity of disinfectants. Calendula is having anti-inflammatory propertiesthat help to reduce the irritation of eyes caused by pollutants. It iseffective against itching and inflammations of eyes. Hamamelis water is usedfor external eye preparations such as eye drops and eye wash. It is aTraditional herbal medicinal product for the temporary relief of discomfort ofeye due to continuous exposure to wind and sun. Boric acid to create a stablebalance that resists changes in the solution’s pH. Citrate Buffer (SodiumCitrate & Citric Acid) is the most physiologic of all the common buffers,as it’s a natural buffer occurring in tears.
PreservativeFree Eye Drops with Calendula and Hamamelis extract can be used to protect the eye fromirritations/discomfort due to continuous use of computer/TV/exposedpollution/dry environment and use of contact 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 complaint such as eye irritationItchiness, discomfort of eyes due to the continuous use of computer/TV/exposedpollution/dry environment will be screened at Day 0 and if they meet theinclusion and exclusion criteria, then they will be selected for the study. Atotal of 144 subjects will be recruited for this study forthe PreservativeFree Eye Drops with Calendula and Hamamelis 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 from the PI/CO-PI by a medical practitioner.
- •The inclusion criteria for the subjects for this study are as follows: -Subjects who experience Irritation, 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 -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
The primary objective is to confirm clinical safety and performance of the product Sodium Chloride (0.75%) Eye Drops (eye drop with herbal extract) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, Schirmers test considering the baseline from the initial visit and obtained during the follow up visits. If the end user is a contact lens wearer contact lens characteristics will also be measured at the end of the study
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)