Dry Eye SyndromesPhase 2NCT05733624
Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis
A Phase 2 study testing SCAI-001 0.01% eyedrop, SCAI-001 0.02% eyedrop and Restasis 0.05% eyedrop in people with Dry Eye Syndromes, run by SCAI Therapeutics at 11 sites in South Korea.
Trial summary
This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- SCAI-001 0.01% eyedrop, SCAI-001 0.02% eyedrop and Restasis 0.05% eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 5 Jan 2023to 2 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female who over 19 years old
- Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
- Those who meet below criteria at least one of two eyes;
- Those who have over than score 2 in corneal staining test-Oxford grading
- Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
- TBUT(Tear film break-up time) test result should be under 10sec.
- The corrected visual acuity is 0.2 or more.
Who cannot join
- Those who have clinically significant eye disease not related to dry eye syndrome
- Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit
- Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
- Those who have medical history with intraocular surgery 12months before screening visit
- Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes
- Those who have medicated cyclosporine eye-drops 6weeks before screening visit
Show all 10Show fewer
- Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
- Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
- Those who have received other investigational drugs/devices 30 days before screening visit
- Those who are inappropriate for participating in this study according to investigator's judgement
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
The Catholic University of korea, Bucheon ST.Mary's Hospital
Bucheon-si
Inje University Busan Paik Hospital
Busan
Pusan National Univ. Hospital
Busan
Kyungpook National University Hospital
Daegu
Asan Medical Center
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Yonsei University Wonju Severance Christian Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease
This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- SCAI-001 0.01% eyedrop, SCAI-001 0.02% eyedrop, Restasis 0.05% eyedrop
- Keywords
- Dry Eye, Cyclosporine
- 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.
SCAI-001 0.01% eyedropDrug
Also called Cyclosporine 0.01%
BID for 12weeks
SCAI-001 0.02% eyedropDrug
Also called Cyclosporine 0.02%
BID for 12weeks
Restasis 0.05% eyedropDrug
Also called Cyclosporine 0.05%
BID for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| SCAI-001 0.01% | Experimental | Cyclosporine 0.01% Receives: Drug: SCAI-001 0.01% eyedrop |
| SCAI-001 0.02% | Experimental | Cyclosporine 0.02% Receives: Drug: SCAI-001 0.02% eyedrop |
| Restasis | Active comparator | Cyclosporine 0.05% Receives: Drug: Restasis 0.05% eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear volume
Schirmer's test
Measured: Change from baseline at 12 weeks
Secondary outcomes (7)
Tear volume
Schirmer's test
Measured: Change from baseline at 4, 8 weeks
Corneal staining score with fluorescein
Oxford grading
Measured: Change from baseline at 4, 8, 12 weeks
conjunctival staining score with Lissamine green
Oxford grading
Measured: Change from baseline at 4, 8, 12 weeks
Tear film break-up time
Measured three times and recorded up to 1/100
Measured: Change from baseline at 4, 8, 12 weeks
Standard patient evaluation of eye dryness questionnaire
written by the subject
Measured: Change from baseline at 4, 8, 12 weeks
Ocular surface disease index
written by the subject
Measured: Change from baseline at 4, 8, 12 weeks
Total number of rescue medication used
sourced by patient diary
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start5 Jan 2023
- Primary completion23 Aug 2023
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCAI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee, MD, PhD, Principal investigator, Pusan National Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733624
- Sponsor's protocol ID
- SCAI-001-201
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JH, Kim HK, Shin YJ, Choi CY, Kim HK, Kim E, Kim JY, Lee JE, Kim S, Hwang M, Song JS, Kim DH, Lee JS. Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease. PLoS One. 2026 Sep 28;21(9):e0358007. doi: 10.1371/journal.pone.0358007. eCollection 2026.
PubMed 42804440
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05733624
- Acronym / sponsor ID
- SCAI-001-201
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye, Cyclosporine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- SCAI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 17 Feb 2023 (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 study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCAI-001 0.01% | Experimental | Drug: SCAI-001 0.01% eyedropCyclosporine 0.01% |
| SCAI-001 0.02% | Experimental | Drug: SCAI-001 0.02% eyedropCyclosporine 0.02% |
| Restasis | Active comparator | Drug: Restasis 0.05% eyedropCyclosporine 0.05% |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and Female who over 19 years old
- Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
- Those who meet below criteria at least one of two eyes;
- The corrected visual acuity is 0.2 or more.
Key exclusion criteria (10 listed)
- Those who have clinically significant eye disease not related to dry eye syndrome
- Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit
- Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
- Those who have medical history with intraocular surgery 12months before screening visit
- Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes
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 |
|---|---|---|
| SCAI-001 0.01% eyedropAlso: Cyclosporine 0.01%BID for 12weeks | Drug | SCAI-001 0.01% |
| SCAI-001 0.02% eyedropAlso: Cyclosporine 0.02%BID for 12weeks | Drug | SCAI-001 0.02% |
| Restasis 0.05% eyedropAlso: Cyclosporine 0.05%BID for 12weeks | Drug | Restasis |
Primary outcome
Tear volume
Time frame: Change from baseline at 12 weeks
Schirmer's test
7 secondary outcomes
Tear volume
Time frame: Change from baseline at 4, 8 weeks
Corneal staining score with fluorescein
Time frame: Change from baseline at 4, 8, 12 weeks
conjunctival staining score with Lissamine green
Time frame: Change from baseline at 4, 8, 12 weeks
Tear film break-up time
Time frame: Change from baseline at 4, 8, 12 weeks
Standard patient evaluation of eye dryness questionnaire
Time frame: Change from baseline at 4, 8, 12 weeks
Ocular surface disease index
Time frame: Change from baseline at 4, 8, 12 weeks
Total number of rescue medication used
Time frame: 12weeks
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 5 Feb 2024.
- Derived from this study: PubMed 42804440Kim JH, Kim HK, Shin YJ, Choi CY, Kim HK, Kim E, Kim JY, Lee JE, Kim S, Hwang M, Song JS, Kim DH, Lee JS. Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease. PLoS One. 2026 Sep 28;21(9):e0358007. doi: 10.1371/journal.pone.0358007. eCollection 2026.
- 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.
Lee, MD, PhD principal investigator
Pusan National Univ. Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCAI-001 0.01% eyedrop, SCAI-001 0.02% eyedrop and Restasis 0.05% eyedrop in people with Dry Eye Syndromes, run by SCAI Therapeutics at 11 sites 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 7 inclusion and 10 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 5 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 11 sites 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. 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?
Tear volume (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05733624, which also lists 1 linked publication.
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 5 Feb 2024.