A post market clinical follow up prospective study to evaluate safety and performance of Eye Drops With (Herbal Extract) ( Sodium Hyaluronate) With Euphrasia Extract Eye Drops
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The primary objective is to confirm clinical safety and performance of the product Sodium hyaluronate with Euphrasia extract (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 follow up prospective study to evaluate safety and performance of Eye Drops With Herbal Extract / Sodium Hyaluronate With Euphrasia Extract Eye Drops
Sodium hyaluronate with Euphrasia extract eye drops used to relieve eye discomfort and soreness due to environmental factors. Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Sodium hyaluronate has water retaining properties and provides a low resistance to blinking. It is highly effective at entrapping water and preventing evaporation; this prolongs any beneficial effects. Sodium Hyaluronate (SH) is a glycosaminoglycan, present in natural tears, with excellent viscoelastic; lubricating and water retention properties. Its retention time on the ocular surface is high. HA spreads easily and evenly over the ocular surface, providing effective lubrication in very dry/irritated eyes. Disodium edetate is a cationic chelating agent that binds free metals and enhances antimicrobial activity of disinfectants. Euphrasia has antimicrobial effect. Helps treating the eyes. Euphrasia is used in eye baths and eye drops, for watery, reddened and irritated eyes, for swollen eyelids, for sticky eyes in the morning and against tired, overstrained eyes. Boric Acid to create a stable balance that resists changes in the solution’s pH, Sodium chloride is an Electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells.
Sodium hyaluronate with Euphrasia extract eye drops can be used to protect the eye from irritations/dryness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment and use of contact lenses.
There will be 4 follow up visits expected after using the product:
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 dryness, 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 dryness/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 complaints such as eye dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment will be screened at Day 0 and if they meet the inclusion and exclusion criteria, then they will be selected for the study. A total of 72 subjects will be recruited for this study for the Sodium hyaluronate with Euphrasia extract eye drops).
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 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 hyaluronate with Euphrasia extract eye drops ) -Subjects with existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye drop medications.
结局指标
主要结局
The primary objective is to confirm clinical safety and performance of the product Sodium hyaluronate with Euphrasia extract (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 Sodium Hyaluronate with Euphrasia Extract Eye Drops for prolonged period to ensure acceptability of benefit risk ratio of the Sodium Hyaluronate with Euphrasia Extract Eye Drops, 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)