A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Eye Drops).
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- The primary objective is to confirm clinical safety and performance of the product Sodium hyaluronate (eye drop) by performing a set of eye examinations (i.e. visual acuity test, IOP measurement, corneal staining, TBUT test, Schimer’s Test) considering the baseline from the initial visits and the data 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 Preparations (Eye Drops).
Sodium hyaluronate (HA) eye drops are used to relieve eye discomfort and soreness due to environmental factors. They moisten, soothe and lubricate the surface of the eye, making it feel more comfortable. Sodium hyaluronate is a derivative of hyaluronic acid. 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.
Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Phosphate buffer (disodium hydrogen phosphate & Sodium dihydrogen phosphate dehydrate).Sodium phosphate, buffer, is the most physiologic of all the common buffers, as it’s a natural buffer occurring in tears.
HA 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 drops 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 aprospective, multi-centric, non-randomized study. The subjects visiting thestudy centers with the complaints such as eye dryness, Itchiness, discomfort ofeyes due to the continuous use of computer/TV/exposed pollution/dry environmentwill be screened at Day 0 and if theymeet the inclusion and exclusion criteria, then they will be selected for thestudy. A total of 282 subjects will be recruited for this study forthe 4 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
- •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 comfort/TV/exposed pollution/dry environment.
排除标准
- •Subjects who are not willing to participate in the study -Anyone with known allergic reaction to HA 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 hyaluronate (eye drop) by performing a set of eye examinations (i.e. visual acuity test, IOP measurement, corneal staining, TBUT test, Schimer’s Test) considering the baseline from the initial visits and the data 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 for prolonged period to ensure acceptability of benefit risk ratio of the Eye drop, 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.