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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients in any race, 18 years (inclusive) or older.
- 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.
- 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.
- 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:
- CFS score (NEI scale) 1-12.
- OSDI score 13-50.
- In addition, patients should fulfill the required range of the following assessmentsat 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/orartificial tears (but naïve to HA-containing eye drops) for at least 3 months beforethe screening phase.
Exclusion
Exclusion Criteria:
- 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.
- Patients who have a history of intraocular, lacrimal or ocular surface surgery otherthan cataract extraction.
- Patients who received cataract extraction surgery within 6 months of screening orpatients who are planning to receive eye surgery during the study period.
- Patients who wear corneal contact lens, have history of other severe systemicdiseases, or other conditions, in the Investigator's opinion, may preclude enrollment.
- 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).
- Patients with ocular conditions other than DED requiring topical ophthalmic treatment.
- 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
Connect with a study center
Keelung Chang Gung memorial hospital
Keelung,
TaiwanActive - Recruiting
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