Dry Eye Disease
Conditions
Brief 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).
Interventions
DRUGSY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%
DRUGSY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%
DRUGSY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution 0.5%
DRUGSY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle
Sponsors
Seinda Pharmaceutical Guangzhou Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention model description
Double-masked, parallel, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria 1. Provide written informed consent prior to any study-related procedures. 2. Are 18 years of age or older. 3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study. 4. 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.
Exclusion criteria
1. Unanesthetized Schirmer test score in either eye \<2 mm/5 minutes at Visit 1. 2. 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 3. 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. 4. 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. 5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | 60 days | Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). |
| Change From Baseline in Symptom Severity Score (Subscale) at Day 60 | 60 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SY-201 Ophthalmic Solution 2.0% SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0% | 50 |
| SY-201 Ophthalmic Solution 1.0% SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0% | 51 |
| SY-201 Ophthalmic Solution 0.5% SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5% | 51 |
| SY-201 Ophthalmic Solution Vehicle SY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle | 49 |
| Total | 201 |
Baseline characteristics
| Characteristic | SY-201 Ophthalmic Solution 2.0% | SY-201 Ophthalmic Solution 1.0% | SY-201 Ophthalmic Solution 0.5% | SY-201 Ophthalmic Solution Vehicle | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 31 Participants | 26 Participants | 29 Participants | 115 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 20 Participants | 25 Participants | 20 Participants | 86 Participants |
| Age, Continuous | 65.5 years STANDARD_DEVIATION 12.2 | 64.8 years STANDARD_DEVIATION 10.8 | 65.0 years STANDARD_DEVIATION 9.2 | 64.2 years STANDARD_DEVIATION 13.1 | 64.9 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 48 Participants | 49 Participants | 45 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 0 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 13 Participants | 11 Participants | 10 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 38 Participants | 34 Participants | 40 Participants | 35 Participants | 147 Participants |
| Region of Enrollment United States | 50 participants | 51 participants | 51 participants | 49 participants | 201 participants |
| Sex: Female, Male Female | 36 Participants | 40 Participants | 44 Participants | 35 Participants | 155 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 7 Participants | 14 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 | 0 / 50 | 0 / 48 |
| other Total, other adverse events | 8 / 49 | 3 / 51 | 4 / 50 | 4 / 48 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 | 0 / 50 | 0 / 48 |
Outcome results
Primary
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.
Time frame: 60 days
Population: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 | -18.9 Score on visual analog scale (0 -100) | Standard Deviation 23.3 |
| SY-201 Ophthalmic Solution 1.0% | Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 | -16.9 Score on visual analog scale (0 -100) | Standard Deviation 19.75 |
| SY-201 Ophthalmic Solution 0.5% | Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 | -20.0 Score on visual analog scale (0 -100) | Standard Deviation 21.56 |
| SY-201 Ophthalmic Solution Vehicle | Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 | -14.7 Score on visual analog scale (0 -100) | Standard Deviation 21.56 |
Primary
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).
Time frame: 60 days
Population: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | -2.04 tCFS score on a scale of 0 - 20 | Standard Deviation 1.989 |
| SY-201 Ophthalmic Solution 1.0% | Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | -1.65 tCFS score on a scale of 0 - 20 | Standard Deviation 2.642 |
| SY-201 Ophthalmic Solution 0.5% | Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | -2.15 tCFS score on a scale of 0 - 20 | Standard Deviation 2.409 |
| SY-201 Ophthalmic Solution Vehicle | Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 | -1.54 tCFS score on a scale of 0 - 20 | Standard Deviation 2.598 |
Secondary
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)).
Time frame: 60 days
Population: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | -0.33 Score on a scale of cCFS (mNEI: 0 - 4) | Standard Deviation 0.653 |
| SY-201 Ophthalmic Solution 1.0% | Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | -0.36 Score on a scale of cCFS (mNEI: 0 - 4) | Standard Deviation 0.933 |
| SY-201 Ophthalmic Solution 0.5% | Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | -0.44 Score on a scale of cCFS (mNEI: 0 - 4) | Standard Deviation 0.517 |
| SY-201 Ophthalmic Solution Vehicle | Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 | -0.18 Score on a scale of cCFS (mNEI: 0 - 4) | Standard Deviation 0.641 |
Secondary
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.
Time frame: 60 days
Population: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SY-201 Ophthalmic Solution 2.0% | Change From Baseline in Symptom Severity Score (Subscale) at Day 60 | -19.8 units on a scale 0-100 | Standard Deviation 23.05 |
| SY-201 Ophthalmic Solution 1.0% | Change From Baseline in Symptom Severity Score (Subscale) at Day 60 | -19.7 units on a scale 0-100 | Standard Deviation 25.48 |
| SY-201 Ophthalmic Solution 0.5% | Change From Baseline in Symptom Severity Score (Subscale) at Day 60 | -19.4 units on a scale 0-100 | Standard Deviation 21.09 |
| SY-201 Ophthalmic Solution Vehicle | Change From Baseline in Symptom Severity Score (Subscale) at Day 60 | -11.5 units on a scale 0-100 | Standard Deviation 19.47 |