| CTRI Number |
CTRI/2024/06/068514 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate safety and performance of
Sodium Hyaluronate Ophthalmic Solution |
|
Scientific Title of Study
|
A post market clinical follow up prospective study to evaluate safety and performance of Sodium Hyaluronate Ophthalmic Solution |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KHI/PMCFPR/HA |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Prasannaraj |
| Designation |
Consultant Ophthalmologist and Vitreo Retinal Surgeon |
| Affiliation |
Sabhari Eye Care Hospital and Retina Centre |
| Address |
First floor, Room No.3,
Rajeev Nagar, Bagalur Road, Hosur
Dharmapuri
TAMIL NADU
635109
India |
| Phone |
07708997222 |
| Fax |
|
| Email |
prasannaraj1309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Prasannaraj |
| Designation |
Consultant Ophthalmologist and Vitreo Retinal Surgeon |
| Affiliation |
Sabhari Eye Care Hospital and Retina Centre |
| Address |
First floor, Room No.3,
Rajeev Nagar, Bagalur Road, Hosur
TAMIL NADU
635109
India |
| Phone |
07708997222 |
| Fax |
|
| Email |
prasannaraj1309@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Prasannaraj |
| Designation |
Consultant Ophthalmologist and Vitreo Retinal Surgeon |
| Affiliation |
Sabhari Eye Care Hospital and Retina Centre |
| Address |
First floor, Room No.3,
Rajeev Nagar, Bagalur Road, Hosur
TAMIL NADU
635109
India |
| Phone |
07708997222 |
| Fax |
|
| Email |
prasannaraj1309@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kilitch Healthcare India Ltd.
R-904, 905, T.T.C. Industrial Area, MIDC, Rabale, Navi Mumbai – 400701, Dist: Thane, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Kilitch Healthcare India Ltd. |
| Address |
Kilitch Healthcare India Ltd.
R-904, 905, T.T.C. Industrial Area, MIDC, Rabale, Navi
Mumbai – 400701, Dist: Thane, Maharashtra, India. |
| 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 S Prasannaraj |
Sabhari Eye Care Hospital and Retina Centre |
First floor, Room No.3,
No 33/3, Rajeev Nagar, Bagalur Road, Hosur
Dharmapuri
TAMIL NADU |
07708997222
prasannaraj1309@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 |
| Healthy Human Volunteers |
Eye dryness |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sodium Hyaluronate Ophthalmic
Solution |
Ophthalmologist Device used as Eye Lubricant. Sodium Hyaluronate ophthalmic solution device is intended to be used in
dry eye syndrome, burning sensation due to environmental conditions.
The recommended dose is one or two drops into affected eye two or four times a day as needed or as directed by the doctor for a duration of 2
months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are able to give voluntary, written informed consent to participate in this study.
Subjects who experience eye dryness, eye soreness/ burning, irritative sensation and discomfort
of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment.
|
|
| ExclusionCriteria |
| Details |
Anyone with known allergic reaction to Sodium Hyaluronate Ophthalmic Solution.
Subjects with existing eye infection.
History of ocular surgery. History or active signs of severe or serious ocular conditions such as
inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
Patients participating in any another clinical trial during study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective will be, to confirm clinical safety and performance of the product Sodium
Hyaluronate Ophthalmic Solution from the baseline with follow up visits. |
1st Visit - After 15 days of using the product
2nd Visit - After one month of using the product
3rd Visit - After two months of using the product |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective will be to assess clinical benefits, contraindications and possible misuse/ off-label
use during the use of the product. Also, the continued acceptability of benefit-risk ratio will be ensured
during the study. Overall subject and PI satisfaction will be recorded in the PMCF Checklist. |
1st Visit - After 15 days of using the product
2nd Visit - After one month of using the product
3rd Visit - After two months of using the product |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study will be an open-label, single-armed, single-centric, observational, prospective PMCF study. The subjects visiting the study center with the complaints such as eye dryness, eye soreness/ burning, irritative sensation and discomfort of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment will be screened on Day 0 and if they meet the inclusion and exclusion criteria, then they will be selected for the study. A total of 61 subjects will be recruited for this study, subjects will be undergoing visual acuity test, IOP, corneal staining, Superficial Keratitis, TBUT test, Schirmer’s test. After the consent is signed these subjects will be given. The allocation of Sodium Hyaluronate Ophthalmic Solution will be subjected to eye dryness by the PI. They will be followed up 3 times on Day 15, Day 30 and Day 60 after using the product. At every follow up visit the above-mentioned test, comprehensive eye examination by the Investigator will be performed and apart from these performance and safety tests, benefits, risks, side effects and adverse events will be recorded.
Results- This observational, prospective, single-arm, single-center PMCF study evaluated the safety, performance, and clinical benefits of Sodium Hyaluronate Ophthalmic Solution in 61 subjects over 60 days. All subjects completed three follow-ups, with no adverse events, side effects, residual risks, contraindications, or off-label use reported. Corneal staining remained normal, superficial keratitis was absent, and intraocular pressure and visual acuity stayed within normal ranges, confirming safety. Schirmer’s test values improved (from 17.13/18.3 mm to 25.05/26.62), and TBUT scores increased (from 5.69/5.74 to 8.11/8.44), demonstrating enhanced tear production and tear film stability. Most participants reported relief from dryness (53), burning (59), soreness/irritation (59), and improved comfort during screen use (57), with benefits lasting over two hours. Both PI and subjects rated product performance as good to excellent, with universal satisfaction. Overall, the product proved safe, effective, and well-tolerated, offering moisturizing, soothing, and refreshing benefits without compromising visual quality |