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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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