| CTRI Number |
CTRI/2022/07/043786 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| 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
|
Study is to evaluate safety and performance of Eye Preparations- Sodium Hyaluronate (0.1%, 0.2%, 0.3%, and 0.4%) Eye Drops. |
|
Scientific Title of Study
|
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (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 |
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 |
| 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 Committe |
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 |
| Intervention |
Eye Preparations-Eye drops/Sodium Hyaluronate 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 The eye drops should be applied to the affected eye following the instructions given below.
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.
The duration of the intervention is 90 days. |
| Comparator Agent |
Not Applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-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 comfort/TV/exposed pollution/dry environment.
|
|
| ExclusionCriteria |
| Details |
-Subjects who are not willing to participate in the study
-Anyone with known allergic reaction to HA 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 hyaluronate (eye drop) by performing a set of eye examinations (i.e. visual acuity test, IOP measurement, corneal staining, TBUT test, Schimer’s Test) considering the baseline from the initial visits and the data 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 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 |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
Final Enrollment numbers achieved (Total)= "282"
Final Enrollment numbers achieved (India)="282" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/07/2022 |
| Date of Study Completion (India) |
27/04/2023 |
| 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 follow up prospective study to evaluate safety and performance of Eye Preparations (Eye Drops).Sodium hyaluronate (HA) 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. HA spreads easily and evenly over the ocular surface, providing effective lubrication in very dry/irritated eyes. Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Phosphate buffer (disodium hydrogen phosphate & Sodium dihydrogen phosphate dehydrate).Sodium phosphate, buffer, is the most physiologic of all the common buffers, as it’s a natural buffer occurring in tears. HA 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 at Day 0 and if they
meet the inclusion and exclusion criteria, then they will be selected for the
study. A total of 282 subjects will be recruited for this study for
the 4 eye drops. |