CTRI/2022/07/043857 [Registered on: 08/07/2022] Trial Registered Prospectively
Last Modified On:
04/09/2025
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device Other (Specify) [Eye Wash]
Study Design
Other
Public Title of Study
the study is to evaluate safety and performance of Eye Preparations - Distilled Witch Hazel eye wash
Scientific Title of Study
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations - EYE WASH WITH HERBAL EXTRACT/Distilled Witch Hazel eye wash
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Eye drops soothes and gives comfort to the eyes.To apply the Eye wash with Herbal extract:
•Rinse Eye bath with Eye wash containing Herbal extract 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
The 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-PI by a medical practitioner. The inclusion criteria for the subjects for this study are as follows:
-Subjects who experience irritation, 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 Eye wash with Herbal extract/Distilled witch Hazel Eye Wash
-Subjects with allergic reaction to any eye medication or 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 Eye wash with herbal extract by Distilled Witch Hazel eye wash 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
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
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 with herbal extract for prolonged period to ensure acceptability of benefit risk ratio of the Eye wash with herbal extract, 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.
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
Target Sample Size
Total Sample Size="72" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "72" Final Enrollment numbers achieved (India)="72"
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations - EYE WASH WITH HERBAL EXTRACT/Distilled Witch Hazel eye wash
Distilled Witch Hazel eye wash is used to relieve eye discomfort and soreness due to environmental factors Distilled witch hazel provides temporary relief of redness of the eye due to minor eye irritations. Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Disodium edetate is a cationic chelating agent that binds free metals and enhances antimicrobial activity of disinfectants.
Rose water used for eyewash to instantly soothe your irritated and tired eyes. It can provide instant relief from red or inflammatory eyes and also helps in cleansing the eyes. Boric acid is used to create a stable balance that resists changes in the solution’s pH. Sodium Hydroxide is an alkalizing agent.
Distilled Witch Hazel Eye wash can be used to protect the eye from irritations/soreness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment 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 irritation, soreness, Itchiness, discomfort of eyes due to the continuous use ofcomputer/TV/exposed pollution/dry environment use the Eye wash with Herbal extract to soothes and refreshes the eyes
Intended users
Persons who experience irritation, 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, randomized study. The subjects visiting the study centers with the complaint of eye irritation, soreness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment will be screening 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 Distilled Witch Hazel eye wash as mentioned under name of the devices under study.
Results-
In this PMCF activity, feedback was collected from 72 subjects, of whom 40 were male (56%) and 32 female (44%). The age distribution included 30 subjects between 18–35 years, 35 between 36–55 years, and 7 between 56–75 years. The target population consisted of individuals experiencing eye irritation,itchiness, discomfort, dryness, and strain due to prolonged computer/TV use, pollution, or dry environments. The study was conducted at NalamHomoeo Clinic & RC, Krishnagiri, Tamil Nadu, using Distilled Witch Hazel Eye Wash. On day 8, a transient burning sensation was reported by four subjects, lasting from less than a minute to two minutes; however, no further adverse effects were observed thereafter. The common ocular conditions among participants included dryness, itching, strain, redness, tiredness, watering, and burning.Safety assessments demonstrated no complications related to the eye wash. Intraocular pressure (IOP) of both eyes remained stable, with no significant variation from baseline values (p>0.05). Gender showed no significant effect on IOP, whereas age showed a statistically significant impact (p<0.05). Overall, no major safety issues were observed, and the product was proven safe and clinically beneficial.Clinical performance evaluation revealed that subjects experienced soothing, comfort, moisturization, and refreshed eyes following use. Visual performance was rated as excellent by one subject and good by 71 subjects, indicating improvement. UNDVA values of both eyes showed no significant changes (p>0.05), with gender having no effect; however, visual acuity differed significantly by age in the right eye. Median BCDVA remained stable and within normal range across all visits up to day 90. Overall, visual performance improved, and subjects reported feeling good about the product.
No side effects or adverse events were observed till day 90, confirming safety. Similarly, no residual risks were reported during follow-up. Possible misuses such as failure to follow IFU, use with other eye medications, improper storage, use beyond shelf life, or not closing the product properly were listed, but none were reported in this study.Clinical benefits included eye comfort, relief from soreness, and lasting effects of 2–5 hours post-application, confirming sustained product performance. The benefit–risk ratio was favorable, with no new residual risks identified beyond those already covered in the RMF. The overall product satisfaction as rated by the
PI was “good,” with an average score of 3 for all subjects. Similarly, subjects reported positive experiences at all follow-ups (day 8, 30, 60, and 90), noting relief from soreness, irritation, and improvement in comfort, refreshment, and vision quality.The overall subject experience score was 3, reflecting improved quality of vision and daily life activities. These findings collectively confirm the safety, efficacy, and satisfaction of the Distilled Witch Hazel Eye Wash.