| CTRI Number |
CTRI/2022/07/043790 [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 drops] |
| Study Design |
Other |
|
Public Title of Study
|
The purpose of the study is to evaluate safety and performance of Eye Preparations - Sodium Chloride Eye Drop (0.75%) (Calendula extract plus Hamamelis extract
|
|
Scientific Title of Study
|
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Sodium Chloride Eye Drop (0.75%) (Calendula extract plus Hamamelis extract) |
| 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 |
| Dr Chethan 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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sodium Chloride Eye Drop (0.75%) (Calendula extract plus Hamamelis extract) |
Eye drops Soothes and gives comfort to the eyes.
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.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.
Duration of Intervention is 90 days
|
|
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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, 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 Drop (0.75%) (Calendula extract + Hamamelis extract)
-Subjects with any existing eye infection
-Subjects undergone recent (6weeks) 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 (0.75%) (Calendula extract + Hamamelis extract) by performing a set of eye examinations (i.e.visual acuity test, IOP measurement, corneal staining, Schirmer’s test considering the baseline from the initial visit and obtained during the follow up visits. If the end user is a contact lens wearer contact lens characteristics will also be measured at the end of the study |
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="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) |
29/11/2022 |
| 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 (Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis extract). Sodium Chloride 0.75% Eye drops with calendula + Hamamelis 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. Calendula is having anti-inflammatory properties that help to reduce the irritation of eyes caused by pollutants. It is effective against itching and inflammations of eyes. Hamamelis water is used for external eye preparations such as eye drops and eye wash. It is a Traditional herbal medicinal product for the temporary relief of discomfort due to continuous exposure to wind and sun. Sodium chloride is an electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells.
Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis 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 of computer/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 72 subjects will be recruited for this study for the Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis extract).
Results- The PMCF study was conducted on 72 subjects (34 males, 38 females) aged below 30 years no.17, 30–50 years no.40, and above 50 years no.15, at Nalam Homoeo Clinic & RC, Krishnagiri, Tamil Nadu, to evaluate the safety and performance of Sodium Chloride Eye Drops 0.75% containing Calendula and Hamamelis extracts. The target population included individuals experiencing ocular irritation, itching, discomfort, dryness, redness, watering, and strain due to prolonged screen exposure, pollution, or dry environments. Corneal staining assessments showed no corneal changes across all visits, confirming ocular safety. Intraocular pressure (IOP) remained stable with no clinically significant changes from baseline (p>0.05), unaffected by gender, while age had some effect (p<0.05). Similarly, visual acuity (UNDVA,BCDVA) remained within normal limits, with no significant gender-based differences but with age-related variations, particularly better values in subjects less or equal 40 years. Schirmer’s test demonstrated consistent improvement in tear secretion and moisture retention, with significant differences noted in right eyes by gender and age. Overall, the study confirmed that the eye drops improved ocular lubrication, comfort, soothing effect, and visual performance. No adverse events, side effects, or residual risks were reported during the 90-day follow-up. Possible misuses such as non-adherence to dosage, improper storage, concomitant medication use, or off-label use were identified in theory but not observed in practice. Subjects reported sustained relief from ocular soreness,dryness, and irritation, with the product’s effect lasting 5–8 hours, 12 hours, or even a full day. The clinical benefits outweighed any potential risks, supporting a favorable benefit–risk ratio consistent with the existing risk management file (RMF), with no new risks identified. Both investigator and subject satisfaction were rated good, with an overall score of 3. Subjects consistently reported refreshed, comfortable eyes, improved quality of vision, and better daily activity performance. The principal investigator also rated the product positively, reinforcing the evidence that Sodium Chloride Eye Drops 0.75% with Calendula and Hamamelis extracts are safe, effective, and well tolerated in routine clinical use. |