| CTRI Number |
CTRI/2022/07/043859 [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 - Sodium Hyaluronate Preservative Free Eye Drops. |
|
Scientific Title of Study
|
A post market clinical follow up prospective study to evaluate safety and performance of Preservative free Eye Preparations – Eye Drops/Sodium Hyaluronate Preservative free Eye Drops |
| 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
Bangalore
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
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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
PRESERVATIVE FREE EYE PREPARATIONS -EYE DROPS/ SODIUM HYALURONATE PRESERVATIVE FREE EYE DROPS |
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.
To apply the eye drops:
•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.
Persons who experience dryness/itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment.
The frequency of application of eye drops depends upon Eye dryness condition of the subject.
The study duration for 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 must be which is prescribed 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 Hyaluronate Preservative Free eye drops
-Subjects with existing eye infection
-Subjects undergone recent (6 weeks)cataract surgery who are on other eye drops
|
|
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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 Hyaluronate (Preservative free eye drop) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, TBUT test, Schirmer’s Test) considering the baseline from the initial visit and the data obtained during the follow up visits. If the end user is a contact lens wearer contact lens characteristics will be checked 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 for prolonged period to ensure acceptability of benefit risk ratio of the Eye drop, 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 |
|
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Target Sample Size
|
Total Sample Size="396"
Sample Size from India="396"
Final Enrollment numbers achieved (Total)= "396"
Final Enrollment numbers achieved (India)="396" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/07/2022 |
| Date of Study Completion (India) |
28/06/2023 |
| 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
Modification(s)
|
A post market clinical follow up prospective study to evaluate safety and performance of Preservative free Eye Preparations – Eye Drops/Sodium Hyaluronate Preservative free Eye Drops .Sodium Hyaluronate Preservative free Eye Drops are used to relieve eye discomfort and soreness due to environmental factors. They moisten, soothe and lubricate the surface of the eye, making it feel more comfortable. Sodium hyaluronate is a derivative of hyaluronic acid. Sodium hyaluronate has water retaining properties and provides a low resistance to blinking. It is highly effective at entrapping water and preventing evaporation; this prolongs any beneficial effects. Sodium Hyaluronate (SH) is a glycosaminoglycan, present in natural tears, with excellent viscoelastic; lubricating and water retention properties. Its retention time on the ocular surface is high. Phosphate buffer (disodium hydrogen phosphate & Sodium dihydrogen phosphate dihydrate) and & Citrate Buffer (Sodium Citrate & Citric Acid ) are the most physiologic of all the common buffers, as it’s a natural buffer occurring in tears. Sodium Hyaluronate Preservative free Eye Drops 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 dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment use the eye drops to soothe the eyes. | | Intended users | Persons who experience dryness/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 then they will be selected for the study. A total of 396 subjects will be recruited for this study for the Sodium Hyaluronate Preservative Free Eye Drops.
Results- PMCF studies were conducted at Vivekananda Sevasharama Eye Hospital, Bangalore, to evaluate Sodium Hyaluronate Eye Drops in different concentrations (0.1%, 0.2%, 0.3%) and buffer systems (Citrate and Phosphate), covering 396 subjects across various age groups (17–85 years), with a slightly higher proportion of female participants. The target population included individuals with dryness, irritation, itching, redness, strain, watering, and eye discomfort due to screen exposure, pollution, or dry environments.
Across all formulations, corneal staining remained stable, intraocular pressure (IOP) and visual acuity showed no clinically significant changes, and best corrected distance visual acuity (BCDVA) stayed within the normal range. Schirmer’s test and TBUT consistently demonstrated improved tear film stability and eye moisture, confirming product efficacy, with better results in younger age groups. Contact lens wearers showed no adverse changes in lens characteristics, confirming compatibility.
Safety was well established for 0.1% (Citrate/Phosphate) and 0.3% Citrate formulations, with no adverse events reported. For 0.2% Citrate, only mild, transient discomfort was observed without dropouts. In contrast, with 0.2% Phosphate buffer, some subjects reported irritation/redness on days 8 and 30, leading to dropouts (19 and 11 respectively). Investigation revealed no product quality issues; possible causes included user sensitivity or IFU non-compliance. These events were non-serious, and overall safety remained acceptable.
Clinical performance was consistently positive, with subjects reporting soothing, lubricating, moisturizing, and refreshing effects. Symptom relief lasted 2–5 hours for 0.1% Citrate, 5–8 hours for 0.2% Citrate, and extended up to an entire day for 0.3% Citrate and 0.1%/0.2% Phosphate formulations. Doctors (PIs) rated overall satisfaction as “good” for all subjects, and most participants reported improved comfort, reduced soreness, and better quality of life.In conclusion, all formulations of Sodium Hyaluronate Eye Drops demonstrated strong safety, efficacy, and performance profiles. While transient irritation was observed with the 0.2% Phosphate formulation in a minority of subjects, the overall benefit–risk ratio remained highly favorable across all products. |