| CTRI Number |
CTRI/2022/07/043861 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| 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 purpose of the study is to evaluate safety and performance of Preservative Free Eye Preparations - Preservative Free Eye Drops with Calendula and Hamamelis 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 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 |
DrChethan 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 |
DrChethan 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
KARNATAKA
560070
India |
| Phone |
9600122287 |
| Fax |
|
| Email |
chethan.sadanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChethan 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
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 |
| 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
|
|
|
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 (0.75%) Eye Drops (CALENDULA EXTRACT plus HAMAMELIS EXTRACT) (Preservative Free |
Eye drops soothes and gives comfort to the eyes.
This eye drops are used by persons who experience Irritation /itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment
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 Sodium chloride eye drops
-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 (0.75%) Eye Drops (eye drop with herbal extract) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, Schirmers 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="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" |
|
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
|
A post market clinical follows up prospective study to evaluate safety and
performance of Preservative Free Eye Preparations (Preservative Free Eye Drops
with Calendula Extract + Hamamelis Extract).Preservative
Free Eye Drops with Calendula +Hamamelis 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. 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 of
eye due to continuous exposure to wind and sun. 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 Calendula and Hamamelis extract can be used to protect the eye from
irritations/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 complaint 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 Calendula and Hamamelis extract. |