Evaluating eye drops for dry eye symptoms in rheumatoid arthritis patients

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

This study is testing if SYSTANE™ Hydration Lubricant Eye Drops can help relieve dry eye symptoms in people with rheumatoid arthritis when used alongside steroid treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Keelung)
• Trial ID: NCT06209879 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of SYSTANE™ Hydration Lubricant Eye Drops combined with steroid-based therapy in alleviating dry eye symptoms in patients with rheumatoid arthritis. The study will enroll 40 participants diagnosed with both rheumatoid arthritis and dry eye disease, who will receive the eye drops and a steroid treatment over a 12-week period. The trial will measure improvements in dry eye symptoms after one month of treatment, using established grading criteria for evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stable rheumatoid arthritis and persistent dry eye symptoms.

Not a fit: Patients with uncontrolled rheumatoid arthritis or those not experiencing persistent dry eye symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for rheumatoid arthritis patients suffering from dry eye symptoms.

How similar studies have performed: Previous studies have shown positive outcomes with similar lubricant eye drop therapies in managing dry eye symptoms, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients in any race, 18 years (inclusive) or older.
2. 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.
3. 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.
4. 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:
   1. CFS score (NEI scale) 1-12.
   2. OSDI score 13-50.
5. In addition, patients should fulfill the required range of the following assessments at Visit 2:

   1. OSDI 13-50 scores
   2. Non invasive TBUT 3-10 seconds
   3. Schirmer's test (without anesthesia) 3-10 mm in 5 minutes
   4. CFS (NEI scale) 1-12 scores
6. 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.

Exclusion Criteria:

1. Any known allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome (SJS) or ocular pemphigoid, eyelid or lacrimal disease, any ocular operation within 6 months, grat versus host disease, non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.
2. Patients who have a history of intraocular, lacrimal or ocular surface surgery other than cataract extraction.
3. Patients who received cataract extraction surgery within 6 months of screening or patients who are planning to receive eye surgery during the study period.
4. Patients who wear corneal contact lens, have history of other severe systemic diseases, or other conditions, in the Investigator's opinion, may preclude enrollment.
5. Patients who received poly-pharmacy treatment for the dry eye before enrollment: DED requires topical ophthalmic treatment other than artificial tears and steroids (i.e., exclude auto-serum drops, diquafosol, and cyclosporine eye drops).
6. Patients with ocular conditions other than DED requiring topical ophthalmic treatment.
7. Patients who had experienced anti-rheumatic medication change within 3 months before the screening.

Where this trial is running

Keelung

• Keelung Chang Gung memorial hospital — Keelung, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chi-Chin Sun, M.D/Ph.D — Chang Gung Memorial Hospital
• Study coordinator: Chi-Chin Sun, M.D/Ph.D

Conditions Dry Eye Syndromes; dry eye disease; rheumatoid arthritis; ocular lubricants; hydroxypropyl guar; hyaluronic acid