Clinical trial NCT06209879: Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis
Official title: Managing Dry Eye in Rheumatoid Arthritis Patients With Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Containing Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye Syndromes
Keywords: dry eye disease
rheumatoid arthritis
ocular lubricants
hydroxypropyl guar
hyaluronic acid
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 \[Visits 3 to 5\]).

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.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Change from baseline to the first month.
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Change from baseline to second and third month
measure: Non-invasive tear break-up time (TBUT)
timeFrame: Change from baseline to second and third month
measure: Corneal fluorescein staining (CFS) scores using National Eye Institute scale
timeFrame: Change from baseline to second and third month
measure: Schirmer's test scores
timeFrame: Change from baseline to second and third month
measure: Tear meniscus height
timeFrame: Change from baseline to second and third month
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung memorial hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chi-Chin Sun, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
References: