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

February 5, 2024 updated by: CHI-CHIN-SUN, Chang Gung Memorial Hospital

Managing Dry Eye in Rheumatoid Arthritis Patients With Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Containing Lubricant Eye Drops

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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]).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Keelung, Taiwan
        • Recruiting
        • Keelung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid/Hydroxypropyl Guar arm
Systane Hydration® MD
Drug: SYSTANE™ Hydration Lubricant Eye Drops
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
Other Names:
  • 0.1% FML

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI)
Time Frame: Change from baseline to the first month.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI)
Time Frame: Change from baseline to second and third month
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 second and third month
Non-invasive tear break-up time (TBUT)
Time Frame: Change from baseline to second and third month
TBUT is used to assess the tear film stability by recording the interval between the last blink and the first appearance of a dry spot. TBUT less than 10 sec suggests an abnormal tear film. While TBUT between 5 to 10 sec is considered marginal, TBUT less than 5 sec indicates dry eye.
Change from baseline to second and third month
Corneal fluorescein staining (CFS) scores using National Eye Institute scale
Time Frame: Change from baseline to second and third month
The CFS will be evaluated by external eye photography using the National Eye Institute (NEI) staining grid in which a score of 0 (normal) to 3 (severe) will be assigned to each of the 5 corneal regions (nasal, central, temporal, superior, and inferior). The CFS score will range between 0 and 15, and the maximum score of 15 indicates severe epitheliopathy.
Change from baseline to second and third month
Schirmer's test scores
Time Frame: Change from baseline to second and third month
Schirmer's test is a quantitative test to measure maximal tear secretion capacity. A filter paper will be placed in the lower fornix for 5 min and the and the length of wetted paper is measured.While a Schirmer's test score of greater than 10 mm/5 min is classified as normal, test score of less than 5 mm/5 min indicates tear deficiency.
Change from baseline to second and third month
Tear meniscus height
Time Frame: Change from baseline to second and third month
Tear meniscus height is a quantitative test to measure vertical height of the marginal tear strip
Change from baseline to second and third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chi-Chin Sun, M.D/Ph.D, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73583109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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