CTRI/2022/07/043860 [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 drops]
Study Design
Other
Public Title of Study
the study is to evaluate safety and performance of Preservative Free Eye Preparations - Preservative Free Eye Drops with Chamomile and Euphrasia extract
Scientific Title of Study
A post market clinical follows up prospective study to evaluate safety and performance of Preservative Free Eye Preparations (Preservative Free Eye Drops with Chamomile and Euphrasia extract).
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.
Preservative Free Eye Drops with Chamomile and Euphrasia extract can be used to protect the eye from irritations/ discomfort due to continuous use of computer/TV/exposed pollution/dry environment, use of contact lenses.
It is recommended to use one or two drops into the eye (or eyes). Many people find it is sufficient to use the drops three or four times a day, but it can be used as often as needed. If the drops have been prescribed then follow the directions given by the doctor.
To apply the eye drop with herbal extract:
•Instill one or two drops into each eye when required, or use as directed by your eye care practitioner.
•Blink several times.
•Replace the cap tightly after use.
Duration of intervention is 90 days.
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 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 irritation , 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
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 Preservative Free Eye Drops with Chamomile and Euphrasia extract
-Subjects with 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 Sodium Chloride 0.5% eye drops with Borate and Citrate buffer (eye
drop with herbal extract) by performing a set of eye examinations.
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 drops with herbal extract for prolonged period to ensure acceptability of benefit risk ratio of the eye drop 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.
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="144" Sample Size from India="144" Final Enrollment numbers achieved (Total)= "144" Final Enrollment numbers achieved (India)="144"
A post market clinical follows up prospective study to evaluate safety and performance of Preservative Free Eye Preparations {Preservative Free Eye Drops with Herbal Extract/Sodium Chloride 0.5% Eye Drops with Borate and Citrate Buffer } (Chamomile and Euphrasia extract).
Preservative Free Eye Drops with Chamomile and Euphrasia herbal extract are used to relieve eye discomfort and soreness due to environmental factors Sodium chloride is an Electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells. Disodium edetate is a cationic chelating agent that binds free metals and enhances antimicrobial activity of disinfectants. Chamomile extract used to treat eye inflammation and infection and reported for its antibacterial, anti-inflammatory, astringent properties. Cooled chamomile infusion can be used for soothe, tired, irritated eyes. Euphrasia has antimicrobial effect. Helps treating the eyes. Euphrasia is used in eye baths and eye drops, for watery, reddened and irritated eyes, for swollen eyelids, for sticky eyes in the morning and against tired, overstrained eyes.
Boric acid to create a stable balance that resists changes in the solution’s pH. Citrate Buffer (Sodium Citrate & Citric Acid) is the most physiologic of all the common buffers, as it’s a natural buffer occurring in tears.
Preservative Free Eye Drops with Chamomile and Euphrasia extract can be used to protect the eye from irritations/ discomfort due to continuous use of computer/TV/exposed pollution/dry environment, 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
IIntended purpose
Persons who experience irritation, Itchiness, discomfort of eyes due to the continuous use ofcomputer/TV/exposed pollution/dry environment use the eye drop with herbal extract to soothe the eyes.
IIntended users
Persons who experience irritation/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 irritation, 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 144 subjects will be recruited for this study for the Preservative Free Eye Drops with Chamomile and Euphrasia extract.
Results-
Results-
Sodium Chloride Eye Drops (0.5%) (Chamomile plus Euphrasia) with Citrate Buffer (Preservative Free)A PMCF study was conducted in 72 subjects (30 male, 42 female) at Nalam Homoeo Clinic, Tamil Nadu, with ages ranging from below 20 to above 60 years. Four subjects discontinued (due to mild irritation, continuous adverse reaction, or unwillingness to continue). One subject was a contact lens wearer. Target patients included individuals with ocular dryness, redness, itching, irritation, and discomfort caused by screen exposure, pollution, or dry environments.
Clinical safety was confirmed, with no major complications or device-related events reported. IOP remained stable with no significant gender-related variation (p>0.05), though age showed a significant effect on IOP. Similarly, visual acuity (UNDVA, BCDVA) remained stable, with no significant gender effect but a significant age-related variation (better performance in smaller and equal 40 years). Corneal staining remained normal throughout. Schirmer’s test demonstrated improved eye moisture, with statistically significant reduction in dryness requiring at least one month of use. Contact lens compatibility was confirmed, with no changes in base curve, power, or diameter.
Mild burning/irritation was reported in 11 subjects (Day 8), 20 subjects (Day 30), 20 subjects (Day 60), and 21 subjects (Day 90). Complaint investigation and root cause analysis confirmed batch compliance; possible causes included individual hypersensitivity to ingredients or non-compliance with IFU. Events were non-serious, with one dropout due to discomfort.
Clinical benefits included improved comfort, relief from soreness, moisturized eyes, and refreshed visual experience lasting 5–8 hours. Overall satisfaction was rated “good” (average score 3) by both PI and subjects. The benefit–risk ratio was favorable, with benefits outweighing mild non-serious adverse events, requiring no RMF update.
Sodium Chloride Eye Drops (0.5%) (Chamomile plus Euphrasia) with Borate Buffer (Preservative Free)
A parallel PMCF study was conducted in 72 subjects (33 male, 39 female) at Nalam Homoeo Clinic, Tamil Nadu. The study population included mainly adults aged 20–40 years, with three subjects under 20 and eight above 40. One subject was a contact lens wearer. Target patients had ocular dryness, itching, burning, redness, and discomfort.
Clinical safety was established with no complications or adverse events. IOP and visual acuity values remained stable with no significant gender or age-related effects (p>0.05). Corneal staining showed no changes during follow-up. Schirmer’s test confirmed improved eye hydration, demonstrating statistically significant reduction in dryness after one month of continuous use. Contact lens compatibility was confirmed, with no changes in lens parameters.
No side effects or adverse events were observed during the 90-day follow-up, confirming strong tolerability of the borate-buffered formulation.
Clinical benefits included eye comfort, relief from soreness, and improved visual performance, with effect lasting 5–8 hours. Both PI and subjects rated overall satisfaction as “good” (average score 3), with improved daily quality of life reported. The benefit–risk ratio was strongly favorable, with no residual risks identified, and no RMF update required.