The purpose of the study is to evaluate safety and performance of Eye Preparations - HPMC EYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash )
- Conditions
- Cataract in diseases classified elsewhere,
- Registration Number
- CTRI/2022/07/043794
- Lead Sponsor
- STERICON PHARMA PRIVATE LIMITED
- Brief Summary
A post market clinical follow up prospective study to evaluate safety andperformance of Eye Preparations - EYE WASH HydroxyPropyl Methyl Cellulose Eye Wash HPMC EYE WASH(Hydroxy Propyl Methyl Cellulose Eye Wash ) are used to relieve eye discomfort and soreness due toenvironmental factors Polyhexamethylene biguanide binds to thenegatively charged phospholipids found in the microbial plasma membranescausing membrane disruption and cellular lysis. Hypromellose prolong the retention time and improve adhesionof synthetic tears to the cornea and conjunctiva. Disodium edetate is acationic chelating agent that binds free metals and enhances antimicrobialactivity of disinfectants.
Potassium chloride acts as tonicity agentsthat maintain the osmolarity to that of the tear film and Disodium Hydrogen Phosphate and Sodium dihydrogen PhosphateDihydrate Buffering agents added in the product maintains the pH to that of thetear film properties. Phosphate buffer (disodium hydrogen phosphate &Sodium dihydrogen phosphate dehydrate are the most physiologic of common buffers; they arenon-toxic to cells and mimic certain components of extracellular fluids.Sodium Hydroxide is an alkalizing agent. Sodium chloride is an Electrolyteadded to maintain osmolarity as high osmolarity products pull water fromepithelial cells.
HPMCEYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash) can be used to protect theeye from irritations/ soreness/discomfort due to continuous use ofcomputer/TV/exposed pollution/dry environment and the discomfort of using contactlenses.
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
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|Intended purpose
Persons who experience dryness, soreness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment use the Eye wash to soothes and refreshes the eyes
|Intended users
Persons who experience dryness, 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, non-randomized study.The subjects visiting the study centers with the complaints such as eyedryness, Itchiness, discomfort of eyes due to the continuous use ofcomputer/TV/exposed pollution/dry environment will be screened at Day 0 and ifthey meet the inclusion and exclusion criteria, then they will be selected forthe study. A total of 72 subjects will berecruited for this study for the HPMCEYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
- 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-I by a medical practitioner.
- The inclusion criteria for the subjects for this study are as follows: -Subjects who experience, dryness, soreness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment.
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 wash -Subjects with allergic reaction to eye wash -Subjects with any existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye medications.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to confirm clinical safety and performance of the product Hydroxy Propyl Methyl Cellulose Eye Wash by 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 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
- Secondary Outcome Measures
Name Time Method 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 for prolonged period to ensure acceptability of benefit risk ratio of the Eye wash, 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
Trial Locations
- Locations (1)
Vivekananda Eye Hospital, Bengaluru, Karnataka
🇮🇳Bangalore, KARNATAKA, India
Vivekananda Eye Hospital, Bengaluru, Karnataka🇮🇳Bangalore, KARNATAKA, IndiaDrChethan S SadanandPrincipal investigator9600122287chethan.sadanand@gmail.com