Study to evaluate safety and performance of Eye Preparations - Carmellose Sodium Eye Drops

Not Applicable

Completed

Conditions: Cataract in diseases classified elsewhere,

Registration Number: CTRI/2022/07/043791

Lead Sponsor: STERICON PHARMA PRIVATE LIMITED

Brief Summary: A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Carmellose Sodium Eye Drops).

Carmellose Sodium 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. Carboxymethylcellulose is a cellulose derivative that consists of the cellulose backbone made up of glucopyranose monomers and their hydroxyl groups bound to carboxymethyl groups. Itâ€™s viscous and mucoadhesive properties as well as its anionic charge allow prolonged retention time in the ocular surface. It exhibits protective actions on the ocular surface in various applications.

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 dihydrate).Sodium phosphate, buffer, is the most physiologic of all the common buffers, as itâ€™s a natural buffer occurring in tears.

Carmellose Sodium 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

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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 aprospective, multi-centric, non-randomized study. The subjects visiting thestudy centers with the complaints such as eye dryness, Itchiness, discomfort ofeyes due to the continuous use of computer/TV/exposed pollution/dry environmentwill be screened at Day 0 and if they meet the inclusion and exclusioncriteria, then they will be selected for the study. A total of 54 subjects will be recruited for this study for the Carmellose Sodium eye drops.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 54

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 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 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 Carmellose Sodium eye drops -Subjects with any existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye medication.

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 Carmellose (Eye drop) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, TBUT test, 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 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
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Bangalore, KARNATAKA, India
Vivekananda Eye Hospital, Bengaluru, Karnataka
🇮🇳Bangalore, KARNATAKA, India
DrChethan S Sadanand
Principal investigator
9600122287
chethan.sadanand@gmail.com