Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study.

ABSTRACT:

Introduction

This work aimed to evaluate the safety and efficacy of hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricating drops in Indian subjects with dry eye disease (DED).

Methods

This prospective, open-label, single-arm, phase IV study was conducted in India.

Inclusion criteria

Adults (18-65 years) with an average total ocular surface staining (TOSS) score ≥ 4, best-corrected visual acuity of ≥ 20/40 in each eye, tear break-up time (TBUT) ≤ 10 s, and dry eye questionnaire (DEQ-5) score ≥ 6. Subjects received the first dose of HPG-HA eye drops on day 1 and self-administered 1-2 drops four times daily for 90 ± 5 days.

Primary endpoints

Frequency and characteristics of treatment-emergent adverse events (TEAEs) throughout the study and TOSS score

SUBMITTER: Awisi-Gyau D 

PROVIDER: S-EPMC11754552 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature