Dry Eye DiseasePhase 1/2NCT05370495
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
A Phase 1/2 study testing SY-201 Ophthalmic Solution 2.0%, SY-201 Ophthalmic Solution 1.0% and SY-201 Ophthalmic Solution 0.5% in people with Dry Eye Disease, run by Seinda Pharmaceutical Guangzhou Corporation at 1 site in United States.
Trial summary
This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- SY-201 Ophthalmic Solution 2.0%, SY-201 Ophthalmic Solution 1.0% and SY-201 Ophthalmic Solution 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 24 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to any study-related procedures.
- Are 18 years of age or older.
- Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
- Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.
Who cannot join
- Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1.
- Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
- Have corneal erosive disease (e.g., confluent staining [National Eye Institute (NEI) grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
- Have a history of glaucoma or intraocular pressure (IOP) >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye.
- Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease
This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).
- Conditions
- Dry Eye Disease
- Being tested
- SY-201 Ophthalmic Solution 2.0%, SY-201 Ophthalmic Solution 1.0%, SY-201 Ophthalmic Solution 0.5%, SY-201 Ophthalmic Solution Vehicle
- 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.
SY-201 Ophthalmic Solution 2.0%Drug
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 1.0%Drug
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 0.5%Drug
SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution VehicleDrug
SY-201 Ophthalmic Solution Vehicle
| Study group | Role | What they receive |
|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Experimental | SY-201 Ophthalmic Solution 2.0% Receives: Drug: SY-201 Ophthalmic Solution 2.0% |
| SY-201 Ophthalmic Solution 1.0% | Experimental | SY-201 Ophthalmic Solution 1.0% Receives: Drug: SY-201 Ophthalmic Solution 1.0% |
| SY-201 Ophthalmic Solution 0.5% | Experimental | SY-201 Ophthalmic Solution 0.5% Receives: Drug: SY-201 Ophthalmic Solution 0.5% |
| SY-201 Ophthalmic Solution Vehicle | Placebo comparator | SY-201 Ophthalmic Solution Vehicle Receives: Drug: SY-201 Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
Measured: 60 days
Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60
Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.
Measured: 60 days
Secondary outcomes (2)
Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60
Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)).
Measured: 60 days
Change From Baseline in Symptom Severity Score (Subscale) at Day 60
Symptom severity score sub scale is measured of severity scale of symptoms associated with dry eye using visual analog scale (0 (none) -100 (severe)). This self reported Dry eye symptoms severity score sub scale measures the extent of any ocular discomfort (symptoms), including but not limited to dryness, ocular pain or other type of symptoms.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start25 Jul 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-masked, parallel, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seinda Pharmaceutical Guangzhou Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370495
- Sponsor's protocol ID
- SY201-CS201
- Status last verified
- Nov 2024
- First submitted
- 6 May 2022
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05370495
- Acronym / sponsor ID
- SY201-CS201
- Conditions
- Dry Eye Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Seinda Pharmaceutical Guangzhou CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Posted 26 Nov 2024
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, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-masked, parallel, randomized
| Arm | Type | Receives |
|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Experimental | Drug: SY-201 Ophthalmic Solution 2.0%SY-201 Ophthalmic Solution 2.0% |
| SY-201 Ophthalmic Solution 1.0% | Experimental | Drug: SY-201 Ophthalmic Solution 1.0%SY-201 Ophthalmic Solution 1.0% |
| SY-201 Ophthalmic Solution 0.5% | Experimental | Drug: SY-201 Ophthalmic Solution 0.5%SY-201 Ophthalmic Solution 0.5% |
| SY-201 Ophthalmic Solution Vehicle | Placebo comparator | Drug: SY-201 Ophthalmic Solution VehicleSY-201 Ophthalmic Solution Vehicle |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
- Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1.
- Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
- Have corneal erosive disease (e.g., confluent staining [National Eye Institute (NEI) grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
- Have a history of glaucoma or intraocular pressure (IOP) >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye.
- Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
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 |
|---|---|---|
| SY-201 Ophthalmic Solution 2.0%SY-201 Ophthalmic Solution 2.0% | Drug | SY-201 Ophthalmic Solution 2.0% |
| SY-201 Ophthalmic Solution 1.0%SY-201 Ophthalmic Solution 1.0% | Drug | SY-201 Ophthalmic Solution 1.0% |
| SY-201 Ophthalmic Solution 0.5%SY-201 Ophthalmic Solution 0.5% | Drug | SY-201 Ophthalmic Solution 0.5% |
| SY-201 Ophthalmic Solution VehicleSY-201 Ophthalmic Solution Vehicle | Drug | SY-201 Ophthalmic Solution Vehicle |
Primary outcome
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
Time frame: 60 days
Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60
Time frame: 60 days
Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.
2 secondary outcomes
Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60
Time frame: 60 days
Change From Baseline in Symptom Severity Score (Subscale) at Day 60
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SY-201 Ophthalmic Solution 2.0%, SY-201 Ophthalmic Solution 1.0% and SY-201 Ophthalmic Solution 0.5% in people with Dry Eye Disease, run by Seinda Pharmaceutical Guangzhou Corporation at 1 site in United States.
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 4 inclusion and 5 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 26 Nov 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 (time frame: 60 days). The study lists 2 primary outcomes in all. 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 26 Nov 2024.