A post market clinical follow up study of Sodium Hyaluronate 0.2% Eye Drops

A post market clinical follow up prospective study to evaluate safety and performance of Sodium Hyaluronate 0.2% Eye Drops - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/02/062929

Enrollment

Registered

2024-02-21

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: H579- Unspecified disorder of eye and adnexa

Interventions

Intervention1: Sodium Hyaluronate 0.2% Eye Drops: Sodium Hyaluronate Eye Drops is intended to be used in temporary dry eye relief, burning and ocular fatigue and other minor complaints of no pathologi

Eligibility

Inclusion criteria

Inclusion criteria: 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, Eye fatigue, contact lens caused dryness, discomfort of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment

Exclusion criteria

Exclusion criteria: Anyone with known allergic reaction to Sodium Hyaluronate 0.2% Eye Drops. 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 Pregnant/lactating women during study period.

Design outcomes

Primary

Measure	Time frame
The primary objective will be, to confirm clinical safety and performance of the product Sodium Hyaluronate 0.2% Eye Drops from the baseline with follow up visits. 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 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 case report form. 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 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 case report form. 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

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Countries

India

Contacts

Public ContactDr Chethan S Sadanand

Chethana Eye Care Centre

chethan.sadanand@gmail.com9900122287

Outcome results

None listed

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