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

NCT06209879 | Recruiting Phase 4

• 1 other identifier: 73583109
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndromes

Keywords

dry eye disease; rheumatoid arthritis; ocular lubricants; hydroxypropyl guar; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  The OSDI score is a 12-item patient-reported outcomes questionnaire with an overall score ranging from 0 to 100 to assess ocular surface symptoms, and the subjects can be categorized as having a normal (0-12), mild (13-22), moderate (23-32), or severe (33-100) ocular surface disease based on their OSDI score.

  Change from baseline to the first month.

Secondary Outcomes (5)

• Ocular Surface Disease Index (OSDI)

  Change from baseline to second and third month

• Non-invasive tear break-up time (TBUT)

  Change from baseline to second and third month

• Corneal fluorescein staining (CFS) scores using National Eye Institute scale

  Change from baseline to second and third month

• Schirmer's test scores

  Change from baseline to second and third month

• Tear meniscus height

  Change from baseline to second and third month

Study Arms (1)

Hyaluronic Acid/Hydroxypropyl Guar arm

EXPERIMENTAL

Systane Hydration® MD

Drug: SYSTANE™ Hydration Lubricant Eye Drops

Interventions

SYSTANE™ Hydration Lubricant Eye Drops DRUG

SYSTANE™ Hydration Lubricant Eye Drops (Hyaluronic Acid \[HA\] 0.15%; Polyethylene Glycol 400 0.4%; Propylene Glycol 0.3%)1-2 drops 4 times a day) and 0.1% FML (1-2 drops 3 times a day) in both eyes for 12 week

Also known as: 0.1% FML

Hyaluronic Acid/Hydroxypropyl Guar arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung memorial hospital

Keelung, Taiwan

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Arthritis, Rheumatoid

Interventions

Fluorometholone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Chi-Chin Sun, M.D/Ph.D

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Chin Sun, M.D/Ph.D

CONTACT

+886-2-24313131; chichinsun@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine Chang Gung University Taoyuan, Taiwan ; Doctor, Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: February 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

TW (1)