the study is to evaluate safety and performance of Preservative Free Eye Preparations - Sodium Hyaluronate Preservative Free Eye Drops.

Not Applicable

Completed

Conditions: Cataract in diseases classified elsewhere,

Registration Number: CTRI/2022/07/043859

Lead Sponsor: STERICON PHARMA PRIVATE LIMITED

Brief Summary: A post market clinical follow up prospective study to evaluate safety andperformance of Preservative free Eye Preparations â€“ Eye Drops/Sodium Hyaluronate Preservative free Eye Drops .

SodiumHyaluronate Preservative free Eye Drops are used torelieve eye discomfort andsoreness due to environmental factors. They moisten, soothe andlubricate the surface of the eye, making it feel more comfortable. Sodiumhyaluronate is a derivative of hyaluronic acid. Sodium hyaluronate has waterretaining properties and provides a low resistance to blinking. It is highlyeffective at entrapping water and preventing evaporation; this prolongs any beneficialeffects. Sodium Hyaluronate (SH) is a glycosaminoglycan, present in naturaltears, 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 mostphysiologic of all the common buffers, as it’s a natural buffer occurring intears.

Sodium Hyaluronate Preservative free Eye Drops can be used to protect the eye fromirritations/dryness/discomfort due to continuous use of computer/TV/exposedpollution/dry environment, and use of contact lenses.

There will be 4 follow up visits expected after using theproduct:

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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|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. Thesubjects visiting the study centers with the complaints such as eye dryness,Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposedpollution/dry environment will be screened then they will be selected for thestudy. A total of 396 subjects will berecruited for this study for the Sodium Hyaluronate PreservativeFree Eye Drops.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 396

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, Schirmerâ€™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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Vivekananda Eye Hospital, Bengaluru, Karnataka
🇮🇳
Bangalore, KARNATAKA, India
Vivekananda Eye Hospital, Bengaluru, Karnataka
🇮🇳Bangalore, KARNATAKA, India
DrChethan S Sadanand
Principal investigator
9600122287
chethan.sadanand@gmail.com