A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations - EYE WASH WITH HERBAL EXTRACT/Distilled Witch Hazel eye wash
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 Eye wash with herbal extract by Distilled Witch Hazel eye wash performing a set of eye examinations (i.e. -visual acuity test, IOP measurement considering the baseline from the initial visit and obtained during the follow up visits
研究概览
简要总结
A post market clinical follow up prospective study to evaluate safety and performanceof Eye Preparations - EYE WASH WITH HERBAL EXTRACT/DistilledWitch Hazel eye wash
Distilled WitchHazel eye wash is used to relieve eye discomfort and soreness due to environmental factors Distilledwitch hazel provides temporary relief of redness of the eye due to minor eyeirritations. Polyhexamethylene biguanide binds to the negatively chargedphospholipids found in the microbial plasma membranes causing membrane disruptionand cellular lysis. Disodium edetate is a cationic chelating agent that bindsfree metals and enhances antimicrobial activity of disinfectants.
Rose water usedfor eyewash to instantly soothe your irritated and tired eyes. It can provideinstant relief from red or inflammatory eyes and also helps in cleansing theeyes. Boric acid is used to create a stable balance that resists changes in thesolution’s pH. Sodium Hydroxide is an alkalizing agent.
Distilled WitchHazel Eye wash can be used to protect the eye from irritations/soreness/discomfortdue to continuous use of computer/TV/exposed pollution/dry environmentdiscomfort of using 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, soreness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment use the Eye wash with Herbal extract to soothes and refreshes the eyes
|Intended users
Persons who experience irritation, soreness /itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment.
This study will be a prospective, multi-centric, randomized study. Thesubjects visiting the study centers with the complaint of eye irritation, soreness,Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposedpollution/dry environment will be screening at Day 0 and if they meet theinclusion and exclusion criteria, then they will be selected for the study. Atotal of 72 subjects will be recruited for this study forthe Distilled Witch Hazel eye wash as mentioned undername of the devices under study.
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 wash 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, soreness, 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 Eye wash with Herbal extract/Distilled witch Hazel Eye Wash -Subjects with allergic reaction to any eye medication or any existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye medications.
结局指标
主要结局
The primary objective is to confirm clinical safety and performance of the product Eye wash with herbal extract by Distilled Witch Hazel eye wash performing a set of eye examinations (i.e. -visual acuity test, IOP measurement considering the baseline from the initial visit and obtained during the follow up visits
时间窗: 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
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 wash with herbal extract for prolonged period to ensure acceptability of benefit risk ratio of the Eye wash 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.(There will be 4 follow up visits expected after using the product:)