Status:
RECRUITING
Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ans...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Patients who have a history of intraocular, lacrimal or ocular surface surgery other than cataract extraction.
- Patients who received cataract extraction surgery within 6 months of screening or patients who are planning to receive eye surgery during the study period.
- Patients who wear corneal contact lens, have history of other severe systemic diseases, or other conditions, in the Investigator's opinion, may preclude enrollment.
- 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).
- Patients with ocular conditions other than DED requiring topical ophthalmic treatment.
- Patients who had experienced anti-rheumatic medication change within 3 months before the screening.
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06209879
Start Date
February 5 2024
End Date
December 1 2024
Last Update
February 6 2024
Active Locations (1)
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1
Keelung Chang Gung memorial hospital
Keelung, Taiwan