CTRI Number |
CTRI/2022/07/043794 [Registered on: 06/07/2022] Trial Registered Prospectively |
Last Modified On: |
03/09/2025 |
Post Graduate Thesis |
No |
Type of Trial |
PMS |
Type of Study
Modification(s)
|
Medical Device Other (Specify) [Eye wash] |
Study Design |
Other |
Public Title of Study
|
The purpose of the study is to evaluate safety and performance of Eye Preparations - HPMC EYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash ) |
Scientific Title of Study
|
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations - EYE WASH Hydroxy Propyl Methyl Cellulose Eye Wash |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Chethan S Sadanand |
Designation |
MBBS, MS (OPHTHALMIC-SURGEON) |
Affiliation |
Vivekananda Eye Hospital,Bengaluru,Karnataka |
Address |
1st Floor, Room no.4, Vivekananda Eye Hospital, 2951, Esturi Towers, complex, Krishna Rajendra Rd, Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore KARNATAKA 560070 India |
Phone |
9600122287 |
Fax |
|
Email |
chethan.sadanand@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Chethan S Sadanand |
Designation |
MBBS, MS (OPHTHALMIC-SURGEON) |
Affiliation |
Vivekananda Eye Hospital,Bengaluru,Karnataka |
Address |
1st Floor, Room no.4, Vivekananda Eye Hospital, 2951, Esturi Towers, complex, Krishna Rajendra Rd, Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore KARNATAKA 560070 India |
Phone |
9600122287 |
Fax |
|
Email |
chethan.sadanand@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Chethan S Sadanand |
Designation |
MBBS, MS (OPHTHALMIC-SURGEON) |
Affiliation |
Vivekananda Eye Hospital,Bengaluru,Karnataka |
Address |
1st Floor, Room no.4, Vivekananda Eye Hospital, 2951, Esturi Towers, complex, Krishna Rajendra Rd, Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070
Bangalore KARNATAKA 560070 India |
Phone |
9600122287 |
Fax |
|
Email |
chethan.sadanand@gmail.com |
|
Source of Monetary or Material Support
|
STERICON PHARMA PRIVATE LIMITED. |
|
Primary Sponsor
|
Name |
STERICON PHARMA PRIVATE LIMITED |
Address |
STERICON PHARMA PRIVATE LIMITED.
Plot No. 9R, Sub layout of Plot No 9, 1st Phase,
Bommasandra Industrial Area, Bangalore - 560 099
|
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrChethan S Sadanand |
Vivekananda Eye Hospital, Bengaluru, Karnataka |
1st Floor, Room no.4, Vivekananda Eye Hospital, 2951, Esturi Towers, complex, Krishna Rajendra Rd, Siddanna Layout, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070 Bangalore KARNATAKA |
9600122287
chethan.sadanand@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ACE Independent Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
EYE PREPARATIONS -EYE WASH/HYDROXY PROPYL METHYL CELLOLOSE EYE WASH |
HPMC EYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash) can be used to protect the eye from irritations/dryness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment, use of contact lenses.
It is recommended to pour eye wash into the eye bath unit it is 1/3 full. Many people find it is sufficient to use the eye wash three or four times a day, but it can be used as often as needed to if the eyes are very irritated
The Eye wash should be applied to the affected eye following the instructions given below.
To apply the Eye wash:
Rinse Eye bath with Eye wash immediately before and after use.
Gently pour Eye wash into the eye bath until 1/3rd full.
Bend your head slightly forward, holding the eye bath by its base.
Place the eye bath over your eye
Slowly raise your head with your eye open so that the eye wash flows freely over it
Gently rock your head from side to side for at least 30 seconds.
Use as often as required.
Duration of intervention is 90 days.
|
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
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
|
|
ExclusionCriteria |
Details |
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
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
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
|
Outcome |
TimePoints |
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
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
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
15/07/2022 |
Date of Study Completion (India) |
26/04/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
No |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations - EYE WASH Hydroxy Propyl Methyl Cellulose Eye Wash
HPMC EYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash ) are 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. Hypromellose prolong the retention time and improve adhesion of synthetic tears to the cornea and conjunctiva. Disodium edetate is a cationic chelating agent that binds free metals and enhances antimicrobial activity of disinfectants. Potassium chloride acts as tonicity agents that maintain the osmolarity to that of the tear film and Disodium Hydrogen Phosphate and Sodium dihydrogen Phosphate Dihydrate Buffering agents added in the product maintains the pH to that of the tear film properties. Phosphate buffer (disodium hydrogen phosphate & Sodium dihydrogen phosphate dehydrate are the most physiologic of common buffers; they are non-toxic to cells and mimic certain components of extracellular fluids. Sodium Hydroxide is an alkalizing agent. Sodium chloride is an Electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells. HPMC EYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash) can be used to protect the eye from irritations/ soreness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment and the discomfort of using 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, 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 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 HPMC EYE WASH (Hydroxy Propyl Methyl Cellulose Eye Wash).
Result- A PMCF study of Hydroxy Propyl Methyl Cellulose Eye Wash was conducted at Marigold Hospital, Bangalore, in 72 subjects (14 male, 58 female), aged below 20 years (n=2), 20–40 years (n=62), and 40–60 years (n=8). The target population included individuals experiencing ocular irritation, dryness, itching, strain, redness, watering, burning, or discomfort due to prolonged screen use, pollution, or dry environments. Clinical safety was confirmed as no adverse events, complications, or residual risks were observed during the 90-day follow-up. Intraocular pressure (IOP) and visual acuity (UNDVA, BCDVA) remained stable with no statistically significant variation from baseline (p>0.05), unaffected by age or gender, confirming product safety. Clinical performance outcomes demonstrated consistent improvements in eye comfort, soothing effect, and visual performance, with subjects reporting relief from soreness and eye fatigue. The majority of participants noted that the product’s effects lasted for 5–8 hours, in some cases extending throughout the day. No adverse events or new residual risks were identified, and potential misuse scenarios (e.g., reuse of leftover solution, compromised hygiene, improper storage, use beyond shelf life, or deviation from IFU) were recognized but not reported in this study. The benefit–risk ratio was favorable, with clinical benefits outweighing potential risks, and no update to the existing RMF was required. Both the principal investigator and study participants rated the overall product satisfaction as “good” (average score 3), with subjects reporting improved comfort, relief from irritation, enhanced visual quality, and better daily activity performance. In conclusion, Hydroxy Propyl Methyl Cellulose Eye Wash demonstrated a strong safety and efficacy profile, with high user satisfaction and a favorable benefit–risk balance in real-world use. |