Dry Eye SyndromePhase 2NCT03723798
Clinical Study to Investigate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.
A Phase 2 study testing SA001 Low dose, SA001 Mid dose and SA001 High dose in people with Dry Eye Syndrome, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a phase 2, multicenter, double-blind, placebo control, randomized study to evaluate the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry Eye Syndrome. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- SA001 Low dose, SA001 Mid dose and SA001 High dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Nov 2017to 8 Oct 2018
- Phase
- Phase 2
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 19
- Patient who meets all of the following criteria in at least one of both eyes
- Fluorescein corneal staining score ≥ 2
- Schirmer test ≤ 10mm in 5 mins
- Tear break-up time ≤ 10 secs
- Patient who diagnosed with dry eye syndrome at the time of screening and who have dry eye symptoms (dryness, discomfort, foreign body sensation, pain, vision fluctuation, etc.)
- Patient who agrees not to use eye drops other than the rescue drugs provided during the clinical trial period
- Patient who can understand the clinical trial and voluntarily signs an informed consent
Who cannot join
- Clinically significant ophthalmic diseases not caused by dry eye disease (corneal surface disease, abnormal corneal sensitivity, abnormal tear excess, etc.) that may confuse the interpretation of clinical trial results
- In case of being treated with anti-inflammatory therapy for dry eye, such as steroid or non-steroidal anti-inflammatory eye drops, autologous serum eye drops, etc.
- In case of administration of steroids or immunosuppressants (azathioprine, tacrolimus, cyclosporine, mofetil mycophenolate, etc.)
- Patient who has worn contact lenses within 72 hours prior to screening or need to wear contact lenses during the clinical trial period
- A history of intraocular surgery within 90 days prior to screening
- Active eye infection symptoms such as anterior uveitis, anterior blepharitis, and Steven-Johnson syndrome
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- Patient with an eye allergy or who are currently receiving treatment for an allergic eye disease (using antihistamines, etc.)
- Autoimmune disease (ex. Sjögren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease, etc.)
- Patient who needs surgery due to surface elevation caused by Meibomian Gland Dysfunction (MGD)
- A history of corneal transplantation or neurotrophic keratitis
- Patient who has an intraocular pressure of 25 mmHg or higher in one or more of both eyes or have been diagnosed with glaucoma
- Patient who has undergone vision correction surgery such as LASIK (Laser-Assisted in Situ Keratomileusis) within 12 months prior to screening
- Patient who has undergone silicone lacrimal punctal occlusion or cauterization of the punctum within 90 days prior to screening. However, patient who has undergone collagen lacrimal punctal occlusion can be enrolled.
- Hypersensitivity to the ingredients of the investigational product including rebamipide
- Clinically significant liver, kidney, nervous system, immune system, respiratory or endocrine disease, blood/tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or a history of those diseases
- Patient who shows the following examination findings at visit 1 (screening visit)
- WBC ≤ 4,000/mm3
- Platelets ≤ 100,000/mm3
- AST/ALT/ALP ≥ 3 times the upper limit of normal(ULN)
- Total bilirubin ≥ 1.5 times the upper limit of normal(ULN)
- A woman who has a positive Serum hCG test at the screening visit (Visit 1), or who does not agree to use at least one effective contraceptive method that is medically acceptable
- Take oral contraceptives during the study period
- Pregnant or lactating women
- A history of drug or alcohol abuse
- Participation in an investigational drug or device trial within 30 days prior to screening
- Any condition that, in the opinion of the investigator, would inappropriate to participate in the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Placebo Controlled, 4-group Parallel Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.
This is a phase 2, multicenter, double-blind, placebo control, randomized study to evaluate the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry Eye Syndrome.
The clinical trial consists of a wash-out period of 14 days, a treatment period of 12 weeks, and a follow-up period of 1 week after administration of the Investigational Product. If the subject voluntarily signs the informed consent form(ICF), the investigator conducts screening tests and check medical history to evaluate the subject's suitability. As a result of the screening test, eligible subjects should stop using the prior medication for dry eye syndrome during the 14 days of observation period, and if necessary, subjects can use rescue drug(artificial tears) for the first 11 days, and then discontinue all eye drops including rescue drug(artificial tears) for 3 days. And all of these subjects will be randomized in a 1:1:1:1 ratio to receive 3 different doses of investigational product (SA001 or placebo) everyday for 12 weeks. During the treatment period, If necessary, subjects can use the rescue drug (artificial tears), and the number of administration of rescue drug is limited to 3 times a day, and when used, the administration time should be recorded in the subject's diary.
Subjects should visit to the study site on 2, 4, 8 and 12 weeks after starting dosing investigational product. Efficacy evaluation results are collected from both eyes, and the primary evaluation variable is analyzed using the test results collected from 'Worse eye' (the eye with the worse keratoconjunctival staining result among both eyes). Worse eye will be determined at the baseline visit and, if the results of both eyes are the same, the test result of the left eye is used.
- Conditions
- Dry Eye Syndrome
- Being tested
- SA001 Low dose, SA001 Mid dose, SA001 High dose, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA001 Low doseDrug
3 tablets b.i.d for 12 weeks
SA001 Mid doseDrug
3 tablets b.i.d for 12 weeks
SA001 High doseDrug
3 tablets b.i.d for 12 weeks
PlaceboDrug
3 tablets b.i.d for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | SA001 Low dose Receives: Drug: SA001 Low dose |
| Group 2 | Experimental | SA001 Mid dose Receives: Drug: SA001 Mid dose |
| Group 3 | Experimental | SA001 High dose Receives: Drug: SA001 High dose |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fluorescein Corneal Staining(FCS) score from baseline to Day 84
Measured: Baseline(Day0) and Day 84
Secondary outcomes (6)
Change in Fluorescein Corneal Staining(FCS) score from baseline to Day 14, Day 28 and Day 56
Measured: Baseline(Day0), Day 14, Day 28 and Day 56
Change in Lissamine Green Conjunctival Staining(LGCS) score from baseline to Day 14, Day 28, Day 56 and Day 84
Measured: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Change in Schirmer Test score from baseline to Day 14, Day 28, Day 56 and Day 84
Measured: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Change in Tear Break-Up Time(TBUT) from baseline to Day 14, Day 28, Day 56 and Day 84
Measured: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Change in Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) from baseline to Day 14, Day 28, Day 56 and Day 84
Measured: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Total number of artificial tears use during the 12 weeks of treatment period
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start8 Nov 2017
- Primary completion1 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choun-Ki Joo, M.D.,Ph.D., Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723798
- Sponsor's protocol ID
- SJSA001_03
- Status last verified
- Mar 2022
- First submitted
- 26 Oct 2018
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo Controlled, 4-group Parallel Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.
- ClinicalTrials.gov ID
- NCT03723798
- Acronym / sponsor ID
- SJSA001_03
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 30 Oct 2018 (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.
This is a phase 2, multicenter, double-blind, placebo control, randomized study to evaluate the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry Eye Syndrome.
The clinical trial consists of a wash-out period of 14 days, a treatment period of 12 weeks, and a follow-up period of 1 week after administration of the Investigational Product. If the subject voluntarily signs the informed consent form(ICF), the investigator conducts screening tests and check medical history to evaluate the subject's suitability. As a result of the screening test, eligible subjects should stop using the prior medication for dry eye syndrome during the 14 days of observation period, and if necessary, subjects can use rescue drug(artificial tears) for the first 11 days, and then discontinue all eye drops including rescue drug(artificial tears) for 3 days. And all of these subjects will be randomized in a 1:1:1:1 ratio to receive 3 different doses of investigational product (SA001 or placebo) everyday for 12 weeks. During the treatment period, If necessary, subjects can use the rescue drug (artificial tears), and the number of administration of rescue drug is limited to 3 times a day, and when used, the administration time should be recorded in the subject's diary.
Subjects should visit to the study site on 2, 4, 8 and 12 weeks after starting dosing investigational product. Efficacy evaluation results are collected from both eyes, and the primary evaluation variable is analyzed using the test results collected from 'Worse eye' (the eye with the worse keratoconjunctival staining result among both eyes). Worse eye will be determined at the baseline visit and, if the results of both eyes are the same, the test result of the left eye is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: SA001 Low doseSA001 Low dose |
| Group 2 | Experimental | Drug: SA001 Mid doseSA001 Mid dose |
| Group 3 | Experimental | Drug: SA001 High doseSA001 High dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 19
- Patient who meets all of the following criteria in at least one of both eyes
- Patient who diagnosed with dry eye syndrome at the time of screening and who have dry eye symptoms (dryness, discomfort, foreign body sensation, pain, vision fluctuation, etc.)
- Patient who agrees not to use eye drops other than the rescue drugs provided during the clinical trial period
- Patient who can understand the clinical trial and voluntarily signs an informed consent
Key exclusion criteria (26 listed)
- Clinically significant ophthalmic diseases not caused by dry eye disease (corneal surface disease, abnormal corneal sensitivity, abnormal tear excess, etc.) that may confuse the interpretation of clinical trial results
- In case of being treated with anti-inflammatory therapy for dry eye, such as steroid or non-steroidal anti-inflammatory eye drops, autologous serum eye drops, etc.
- In case of administration of steroids or immunosuppressants (azathioprine, tacrolimus, cyclosporine, mofetil mycophenolate, etc.)
- Patient who has worn contact lenses within 72 hours prior to screening or need to wear contact lenses during the clinical trial period
- A history of intraocular surgery within 90 days prior to screening
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 |
|---|---|---|
| SA001 Low dose3 tablets b.i.d for 12 weeks | Drug | Group 1 |
| SA001 Mid dose3 tablets b.i.d for 12 weeks | Drug | Group 2 |
| SA001 High dose3 tablets b.i.d for 12 weeks | Drug | Group 3 |
| Placebo3 tablets b.i.d for 12 weeks | Drug | Placebo |
Primary outcome
Change in Fluorescein Corneal Staining(FCS) score from baseline to Day 84
Time frame: Baseline(Day0) and Day 84
6 secondary outcomes
Change in Fluorescein Corneal Staining(FCS) score from baseline to Day 14, Day 28 and Day 56
Time frame: Baseline(Day0), Day 14, Day 28 and Day 56
Change in Lissamine Green Conjunctival Staining(LGCS) score from baseline to Day 14, Day 28, Day 56 and Day 84
Time frame: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Change in Schirmer Test score from baseline to Day 14, Day 28, Day 56 and Day 84
Time frame: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Change in Tear Break-Up Time(TBUT) from baseline to Day 14, Day 28, Day 56 and Day 84
Time frame: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Change in Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) from baseline to Day 14, Day 28, Day 56 and Day 84
Time frame: Baseline(Day0), Day 14, Day 28, Day 56 and Day 84
Total number of artificial tears use during the 12 weeks of treatment period
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Choun-Ki Joo, M.D.,Ph.D. principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SA001 Low dose, SA001 Mid dose and SA001 High dose in people with Dry Eye Syndrome, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 8 inclusion and 26 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: finished, as of the sponsor's last update on 18 Mar 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fluorescein Corneal Staining(FCS) score from baseline to Day 84 (time frame: Baseline(Day0) and Day 84). 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 18 Mar 2022.