NCT06209879

Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis

Managing Dry Eye in Rheumatoid Arthritis Patients With Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Containing Lubricant Eye Drops

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy of hydroxypropyl guar-and hyaluronic acid containing lubricant eye drops in rheumatoid arthritis patients . The main question it aims to answer is: • whether adding hydroxypropyl guar-and hyaluronic acid containing lubricant eye drops to steroid-based dry eye therapy improves dry eye symptoms in rheumatoid arthritis patients after 1 month. Participants with rheumatoid arthritis will be treat with SYSTANE™ Hydration Lubricant Eye Drops (1-2 drops 4 times a day) and 0.1% Fluorometholone (1-2 drops 3 times a day) in both eyes for 12 weeks

Detailed description

This is a prospective, single-center study designed to assess the efficacy of adding SYSTANE™ Hydration Lubricant Eye Drops on dry eyes secondary to rheumatoid arthritis (RA) patients. This study will enroll 40 dry-eye RA participants to achieve 32 evaluable participants for analysis. There are 4 phases throughout the whole study, including the screening phase (Day -30 to -14 \[Visit 1\]), the wash-out phase (Day -14±3 days to Day 0), baseline (Day 0 \[Visit 2\]), and the follow-up phase (Days 28±7 to 84±7 days \[Visits 3 to 5\]).

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	SYSTANE™ Hydration Lubricant Eye Drops	SYSTANE™ Hydration Lubricant Eye Drops (Hyaluronic Acid \[HA\] 0.15%; Polyethylene Glycol 400 0.4%; Propylene Glycol 0.3%)1-2 drops 4 times a day) and 0.1% FML (1-2 drops 3 times a day) in both eyes for 12 week

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-01-18
• Last updated: 2024-02-06

Locations

1 site across 1 country: Taiwan