Study is to evaluate safety and performance of Eye Preparations- Sodium Hyaluronate (0.1%, 0.2%, 0.3%, and 0.4%) Eye Drops.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/07/043786

Enrollment

282

Registered

2022-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H28- Cataract in diseases classified elsewhere

Interventions

Intervention1: 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 dry

Eligibility

Inclusion criteria

Inclusion criteria: -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.

Exclusion criteria

Exclusion criteria: -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.

Design outcomes

Primary

Measure	Time frame
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. Timepoint: 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	—

Measure

Time frame

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. Timepoint: 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

Measure	Time frame
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. Timepoint: 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	—

Measure

Time frame

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. Timepoint: 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

—

Countries

India

Contacts

Public ContactDr Chethan S Sadanand

Vivekananda Eye Hospital,Bengaluru, Karnataka

chethan.sadanand@gmail.com9600122287

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026