Managing Dry Eye in Rheumatoid Arthritis Patients With Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Containing Lubricant Eye Drops
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
• Male or female patients in any race, 18 years (inclusive) or older.
• Participants with a confirmed diagnosis of stable RA, determined by a rheumatologist according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria. The systemic conditions of the enrolled patients were well controlled by their rheumatologists during the study period.
• Patients diagnosed with the dry eye disease (DED) by an ophthalmologist based on the Tear Film \& Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II) dry eye severity grading diagnostic scheme criteria.
• At screening, dry eye associated-RA patients on a steroid-based therapy who are stable in dry eye severity but experience/complain of persistent dry eye symptoms.
• The results within the range of the following assessments will be defined as stable DED with persistent dry eye symptoms at the screening phase:
⁃ CFS score (NEI scale) 1-12.
⁃ OSDI score 13-50.
• In addition, patients should fulfill the required range of the following assessments at Visit 2:
‣ OSDI 13-50 scores
⁃ Non invasive TBUT 3-10 seconds
⁃ Schirmer's test (without anesthesia) 3-10 mm in 5 minutes
⁃ CFS (NEI scale) 1-12 scores
• Patients instilled the same dry eye therapeutic regimen of steroid eye drops and/or artificial tears (but naïve to HA-containing eye drops) for at least 3 months before the screening phase.