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

Last updated: February 5, 2024
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Joint Injuries

Rheumatoid Arthritis

Sjogren's Syndrome

Treatment

SYSTANE™ Hydration Lubricant Eye Drops

Clinical Study ID

NCT06209879
73583109
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 rheumatologistaccording to the 2010 American College of Rheumatology (ACR)/European League AgainstRheumatism (EULAR) criteria. The systemic conditions of the enrolled patients werewell controlled by their rheumatologists during the study period.
  3. Patients diagnosed with the dry eye disease (DED) by an ophthalmologist based on theTear Film & Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II) dry eye severitygrading diagnostic scheme criteria.
  4. At screening, dry eye associated-RA patients on a steroid-based therapy who are stablein dry eye severity but experience/complain of persistent dry eye symptoms. The results within the range of the following assessments will be defined as stableDED with persistent dry eye symptoms at the screening phase:
  5. CFS score (NEI scale) 1-12.
  6. OSDI score 13-50.
  7. In addition, patients should fulfill the required range of the following assessmentsat Visit 2:
  8. OSDI 13-50 scores
  9. Non invasive TBUT 3-10 seconds
  10. Schirmer's test (without anesthesia) 3-10 mm in 5 minutes
  11. CFS (NEI scale) 1-12 scores
  12. Patients instilled the same dry eye therapeutic regimen of steroid eye drops and/orartificial tears (but naïve to HA-containing eye drops) for at least 3 months beforethe screening phase.

Exclusion

Exclusion Criteria:

  1. Any known allergy to any of the study medications, conjunctival allergy or infectiousdisease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome (SJS) orocular pemphigoid, eyelid or lacrimal disease, any ocular operation within 6 months,grat versus host disease, non-dry-eye ocular inflammation, trauma, or presence ofuncontrolled systemic disease.
  2. Patients who have a history of intraocular, lacrimal or ocular surface surgery otherthan cataract extraction.
  3. Patients who received cataract extraction surgery within 6 months of screening orpatients who are planning to receive eye surgery during the study period.
  4. Patients who wear corneal contact lens, have history of other severe systemicdiseases, or other conditions, in the Investigator's opinion, may preclude enrollment.
  5. Patients who received poly-pharmacy treatment for the dry eye before enrollment: DEDrequires 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 beforethe screening.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: SYSTANE™ Hydration Lubricant Eye Drops
Phase: 4
Study Start date:
February 05, 2024
Estimated Completion Date:
December 31, 2024

Study 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]).

Connect with a study center

  • Keelung Chang Gung memorial hospital

    Keelung,
    Taiwan

    Active - Recruiting

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