Dry Eye SyndromesPhase 4NCT06209879
Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis
A Phase 4 study testing SYSTANE™ Hydration Lubricant Eye Drops in people with Dry Eye Syndromes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- SYSTANE™ Hydration Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Feb 2024to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Keelung Chang Gung memorial hospital
Keelung
Chi-Chin Sun, M.D/P.D, 2553 ext. 2553, chichinsun@gmail.com
About this study
Official title: 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
Read the 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]).
- Conditions
- Dry Eye Syndromes
- Being tested
- SYSTANE™ Hydration Lubricant Eye Drops
- Keywords
- dry eye disease, rheumatoid arthritis, ocular lubricants, hydroxypropyl guar, hyaluronic acid
- Medical subject headings
- Dry Eye Syndromes, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYSTANE™ Hydration Lubricant Eye DropsDrug
Also called 0.1% FML
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
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid/Hydroxypropyl Guar arm | Experimental | Systane Hydration® MD Receives: Drug: SYSTANE™ Hydration Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to the first month.
Secondary outcomes (5)
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.
Measured: Change from baseline to second and third month
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from baseline to second and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start5 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHI-CHIN-SUN, Chang Gung Memorial Hospital
- Investigators
- Chi-Chin Sun, M.D/Ph.D, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209879
- Sponsor's protocol ID
- 73583109
- Status last verified
- Feb 2024
- First submitted
- 6 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Dry Eye in Rheumatoid Arthritis Patients With Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Containing Lubricant Eye Drops
- ClinicalTrials.gov ID
- NCT06209879
- Acronym / sponsor ID
- 73583109
- Conditions
- Dry Eye Syndromes
- Keywords
- dry eye disease, rheumatoid arthritis, ocular lubricants, hydroxypropyl guar, hyaluronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid/Hydroxypropyl Guar arm | Experimental | Drug: SYSTANE™ Hydration Lubricant Eye DropsSystane Hydration® MD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYSTANE™ Hydration Lubricant Eye DropsAlso: 0.1% FMLSYSTANE™ 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 | Drug | Hyaluronic Acid/Hydroxypropyl Guar arm |
Primary outcome
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.
5 secondary outcomes
Ocular Surface Disease Index (OSDI)
Time frame: 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
Corneal fluorescein staining (CFS) scores using National Eye Institute scale
Time frame: Change from baseline to second and third month
Schirmer's test scores
Time frame: Change from baseline to second and third month
Tear meniscus height
Time frame: Change from baseline to second and third month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Chin Sun, M.D/Ph.D principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SYSTANE™ Hydration Lubricant Eye Drops in people with Dry Eye Syndromes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Chin Sun, M.D/Ph.D (+886-2-24313131 ext. 2553, chichinsun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: Change from baseline to the first month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.