The purpose of the study is to evaluate safety and performance of Eye Preparations - Sodium Chloride Eye Drop (0.5%) (Chamomile extract plus Euphrasia extract)
Scientific Title of Study
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Sodium Chloride Eye Drops (0.5%) (Chamomile extract plus Euphrasia extract)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
(1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not Applicable
Not Applicable
Intervention
Sodium Chloride Eye Drop (0.5%) (Chamomile extract plus Euphrasia extract)
Eye drops soothes and gives comfort to the eyes.It is recommended to use one or two drops into the eye (or eyes) affected by dryness. 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 to if the eyes are very dry. If the drops have been prescribed then follow the directions
given by the doctor.The eye drop with herbal extract should be applied to the affected eye following the instructions given below.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.
the 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 with herbal extract 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, 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 Sodium Chloride Eye Drops (0.5%) (Chamomile extract + Euphrasia extract)
-Subjects with existing eye infection
-Subjects undergone recent (6 weeks) cataract surgery who are on other eye medication
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 Eye Drop (0. 5%) (Chamomile extract + Euphrasia
extract) (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="54" Sample Size from India="54" Final Enrollment numbers achieved (Total)= "54" Final Enrollment numbers achieved (India)="54"
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Sodium Chloride Eye Drops (0.5%) (Chamomile extract + Euphrasia extract)
Sodium Chloride Eye Drops (0.5%) (Chamomile extract + Euphrasia extract)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. 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. Sodium chloride is an Electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells. Sodium Chloride Eye Drop (0. 5%) (Chamomile extract + Euphrasia extract) can be used to protect the eye from irritations/dryness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment and 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
Intended 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.
Intended 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 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 54 subjects will be recruited for this study for the Sodium Chloride Eye Drops (0.5%) (Chamomile extract + Euphrasia extract).
Result-
The PMCF activity was conducted on 54 subjects (28 males, 52%; 26 females, 48%) at Nalam Homoeo Clinic & RC, Krishnagiri District, Tamil Nadu, to evaluate the safety and performance of Sodium Chloride Eye Drops (0.5%) containing Chamomile and Euphrasia extracts. The age distribution included 2 subjects aged 10–18 years, 26 subjects aged 18–40 years, and 26 subjects aged 41–75 years. The target patient population comprised individuals with ocular irritation, itchiness, eye strain, discomfort, dryness, redness, watering, or tiredness related to prolonged screen exposure, pollution, or dry environments.
Corneal staining assessments at day 90 showed a grading of 0 in all subjects, indicating normal corneal condition. The main conditions at baseline included dryness, itching, eye strain, redness,discomfort, watering, burning, and tiredness. Clinical safety was confirmed, with only minor transient issues reported: on day 8, three subjects experienced eye irritation and one reported an allergic reaction; however, no complications were observed beyond day 30. Intraocular pressure (IOP) in both eyes showed no significant variation from baseline (p>0.05), and was unaffected by age or gender.
Clinical performance outcomes were favorable. All subjects reported improvement in soothing effect, comfort, moisture, and refreshed eyes, with corresponding improvements in visual performance. Uncorrected distance visual acuity (UNDVA) remained stable with no significant changes from baseline (p>0.05), unaffected by gender,though age influenced outcomes, with subjects smaller and equal 40 years showing better visual acuity. Best corrected distance visual acuity (BCDVA) remained within normal ranges across all visits. Schirmer’s test showed positive results, confirming the product’s moisturizing effect, with no significant gender- or age-related differences. Overall, subjects’ visual performance improved, and feedback was uniformly positive.No new residual risks were observed, and identified risks from the risk management file (RMF) remain valid. Potential misuse scenarios (e.g., exceeding recommended dose, improper storage, use with other medications, or not following IFU) were listed but not reported during the 90-day follow-up. Clinical benefits included improved eye comfort, relief from soreness and irritation,and sustained effects lasting 5–8 hours, 12 hours, or throughout the day.The benefit–risk ratio was assessed as favorable, with clinical benefits outweighing risks. The principal investigator rated overall product satisfaction as “good” for all subjects, with an average score of 3. Subject satisfaction mirrored this, with participants consistently reporting refreshed, comfortable eyes, relief from soreness, improved quality of vision, and enhanced ability to perform daily activities. Collectively, the study demonstrates that Sodium Chloride Eye Drops (0.5%) with Chamomile and Euphrasia extracts are safe, effective, and well tolerated in routine clinical use.