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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 SYSTANEâ„¢ 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
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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid/Hydroxypropyl Guar arm | Experimental | Systane Hydration® MD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTANEâ„¢ Hydration Lubricant Eye Drops | Drug | SYSTANEâ„¢ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 second and third month |
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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 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:
In addition, patients should fulfill the required range of the following assessments at Visit 2:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi-Chin Sun, M.D/Ph.D | Contact | +886-2-24313131 | 2553 | chichinsun@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chi-Chin Sun, M.D/Ph.D | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung memorial hospital | Recruiting | Keelung | Taiwan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D005469 | Fluorometholone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Non-invasive tear break-up time (TBUT) | 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 | 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 | 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 | Tear meniscus height is a quantitative test to measure vertical height of the marginal tear strip | Change from baseline to second and third month |
| D009140 |
| Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |