A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations- Hypromellose Ophthalmic Solution USPâ€.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The primary objective is to confirm clinical safety and performance of the product Hypromellose Ophthalmic Solution (eye drop) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, TBUT test, Schirmers test) considering the baseline from the initial visits and data obtained from 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 Hypromellose Ophthalmic Solution.
HPMC Ophthalmic Solution is 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. Hypromellose provides lubrication to the ocular surface and maintaining corneal hydration in dry eye conditions. The viscosity promoting properties of Hypromellose prolong the retention time and improve adhesion of synthetic tears to the cornea and conjunctiva.
Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Hypromellose Ophthalmic Solution USP 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.
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 HPMC 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 Hypromellose Ophthalmic Solution (eye drop) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, TBUT test, Schirmers test) considering the baseline from the initial visits and data obtained from 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: Subjects will be followed-up for 4 times after the product use which is on Day 8th, Day 30th, Day 60th and Day 90th. At every follow up visit screening test, comprehensive eye examination by the Investigator will be performed and apart from these tests the product performance, safety, benefits, risks, satisfaction, changes observed in the eye dryness, side effects, and adverse device effect will be checked by asking the quantitative questions from the case report form.
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.(Subjects will be followed-up for 4 times after the product use which is on Day 8th, Day 30th, Day 60th and Day 90th. At every follow up visit screening test, comprehensive eye examination by the Investigator will be performed and apart from these tests the product performance, safety, benefits, risks, satisfaction, changes observed in the eye dryness, side effects, and adverse device effect will be checked by asking the quantitative questions from the case report form.)