Dry Eye
Conditions
Brief summary
SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.
Interventions
DRUGVehicle
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated.
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated.
Sponsors
Silk Technologies, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All investigation product (1% SDP-4 ophthalmic solution and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Intervention model description
Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have DED in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears. * Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2. * Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2. * Anesthetized Schirmer's test tear volume ≥ 3 mm and \<10 mm in both eyes (only at Visit 1). * Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.
Exclusion criteria
* Ocular surface corneal disease other than DED. * Diagnosis of Sjögren's disease. * Lid margin disorder other than meibomian gland dysfunction (MGD) * Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters. * Any previous reconstructive or cosmetic eyelid surgery * Any previous invasive glaucoma and/or corneal surgery * Corneal refractive surgery in the 12 months prior to Visit 1/Screening. * Cataract extraction within 90 days prior to Visit 1/Screening. * Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study. * Contact lens wear. * Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening * Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Assessment in Dry Eye (SANDE) Questionnaire | 56 days | Mean change from baseline in total SANDE at Visit 5/Day 56 The SANDE questionnaire contained two questions regarding the frequency and severity of DED symptoms, with a total score being the square root of the frequency score times the square root of the severity score (range 0 100). A higher score indicates more severe DED symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein Staining | 56 days | Mean and mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of corneal surface irregularity. |
| Tear Breakup Time | 56 days | Mean and mean change from baseline at each visit |
| Conjunctival Hyperemia | 56 days | Mean and mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of conjunctival surface irregularity. |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
| Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness) | 56 days | Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Vehicle
Vehicle: Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated. | 76 |
| SDP-4 Ophthalmic Solution (1.0%) Active
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated. | 77 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Other reasons not specified | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | SDP-4 Ophthalmic Solution (1.0%) | Total | Vehicle |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 14.95 | 60.2 years STANDARD_DEVIATION 15.08 | 61.6 years STANDARD_DEVIATION 15.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 23 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 130 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Blue | 11 Participants | 31 Participants | 20 Participants |
| Iris Color Brown | 45 Participants | 87 Participants | 42 Participants |
| Iris Color Green | 6 Participants | 9 Participants | 3 Participants |
| Iris Color Hazel | 15 Participants | 26 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 25 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 108 Participants | 54 Participants |
| Sex: Female, Male Female | 55 Participants | 107 Participants | 52 Participants |
| Sex: Female, Male Male | 22 Participants | 46 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 77 |
| other Total, other adverse events | 8 / 76 | 8 / 77 |
| serious Total, serious adverse events | 0 / 76 | 1 / 77 |
Outcome results
Primary
Symptom Assessment in Dry Eye (SANDE) Questionnaire
Mean change from baseline in total SANDE at Visit 5/Day 56 The SANDE questionnaire contained two questions regarding the frequency and severity of DED symptoms, with a total score being the square root of the frequency score times the square root of the severity score (range 0 100). A higher score indicates more severe DED symptoms.
Time frame: 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Symptom Assessment in Dry Eye (SANDE) Questionnaire | Screening | 58.95 units on a scale | Standard Deviation 6.635 |
| Vehicle | Symptom Assessment in Dry Eye (SANDE) Questionnaire | Day 56 | -18.80 units on a scale | Standard Deviation 22.288 |
| SDP-4 Ophthalmic Solution (1.0%) | Symptom Assessment in Dry Eye (SANDE) Questionnaire | Screening | 57.21 units on a scale | Standard Deviation 7.85 |
| SDP-4 Ophthalmic Solution (1.0%) | Symptom Assessment in Dry Eye (SANDE) Questionnaire | Day 56 | -16.60 units on a scale | Standard Deviation 19.075 |
Secondary
Conjunctival Hyperemia
Mean and mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of conjunctival surface irregularity.
Time frame: 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Conjunctival Hyperemia | Day 1 Baseline | 0.80 units on a scale | Standard Deviation 0.833 |
| Vehicle | Conjunctival Hyperemia | Day 14 | 0.00 units on a scale | Standard Deviation 0.52 |
| Vehicle | Conjunctival Hyperemia | Day 28 | -0.07 units on a scale | Standard Deviation 0.608 |
| Vehicle | Conjunctival Hyperemia | Day 56 | 0.03 units on a scale | Standard Deviation 0.604 |
| SDP-4 Ophthalmic Solution (1.0%) | Conjunctival Hyperemia | Day 56 | -0.06 units on a scale | Standard Deviation 0.554 |
| SDP-4 Ophthalmic Solution (1.0%) | Conjunctival Hyperemia | Day 1 Baseline | 0.91 units on a scale | Standard Deviation 0.948 |
| SDP-4 Ophthalmic Solution (1.0%) | Conjunctival Hyperemia | Day 28 | -0.03 units on a scale | Standard Deviation 0.53 |
| SDP-4 Ophthalmic Solution (1.0%) | Conjunctival Hyperemia | Day 14 | 0.01 units on a scale | Standard Deviation 0.425 |
Secondary
Corneal Fluorescein Staining
Mean and mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of corneal surface irregularity.
Time frame: 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Corneal Fluorescein Staining | Screening | 0.68 units on a scale | Standard Deviation 0.697 |
| Vehicle | Corneal Fluorescein Staining | Day 14 | -0.21 units on a scale | Standard Deviation 0.664 |
| Vehicle | Corneal Fluorescein Staining | Day 28 | -0.15 units on a scale | Standard Deviation 0.66 |
| Vehicle | Corneal Fluorescein Staining | Day 56 | -0.15 units on a scale | Standard Deviation 0.725 |
| SDP-4 Ophthalmic Solution (1.0%) | Corneal Fluorescein Staining | Day 56 | -0.24 units on a scale | Standard Deviation 0.682 |
| SDP-4 Ophthalmic Solution (1.0%) | Corneal Fluorescein Staining | Screening | 0.74 units on a scale | Standard Deviation 0.696 |
| SDP-4 Ophthalmic Solution (1.0%) | Corneal Fluorescein Staining | Day 28 | -0.22 units on a scale | Standard Deviation 0.809 |
| SDP-4 Ophthalmic Solution (1.0%) | Corneal Fluorescein Staining | Day 14 | -0.04 units on a scale | Standard Deviation 0.772 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging) | -7.89 units on a scale | Standard Deviation 22.985 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging) | -17.06 units on a scale | Standard Deviation 23.356 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort) | -12.10 units on a scale | Standard Deviation 21.195 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort) | -13.18 units on a scale | Standard Deviation 22.283 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness) | -17.97 units on a scale | Standard Deviation 24.768 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness) | -18.38 units on a scale | Standard Deviation 20.921 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain) | -6.94 units on a scale | Standard Deviation 21.2 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain) | -6.47 units on a scale | Standard Deviation 23.4 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision) | -6.17 units on a scale | Standard Deviation 20.025 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision) | -8.11 units on a scale | Standard Deviation 20.654 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation) | -6.94 units on a scale | Standard Deviation 20.567 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation) | -10.58 units on a scale | Standard Deviation 20.031 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching) | -13.81 units on a scale | Standard Deviation 24.411 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching) | -9.75 units on a scale | Standard Deviation 22.89 |
Secondary
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time frame: 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia) | -12.69 units on a scale | Standard Deviation 21.512 |
| SDP-4 Ophthalmic Solution (1.0%) | Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia) | -10.43 units on a scale | Standard Deviation 22.143 |
Secondary
Tear Breakup Time
Mean and mean change from baseline at each visit
Time frame: 56 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Tear Breakup Time | Day 1 | 3.75 seconds | Standard Deviation 1.104 |
| Vehicle | Tear Breakup Time | Day 14 | 1.06 seconds | Standard Deviation 2.57 |
| Vehicle | Tear Breakup Time | Day 28 | 2.00 seconds | Standard Deviation 2.596 |
| Vehicle | Tear Breakup Time | Day 56 | 1.77 seconds | Standard Deviation 2.865 |
| SDP-4 Ophthalmic Solution (1.0%) | Tear Breakup Time | Day 56 | 1.80 seconds | Standard Deviation 2.419 |
| SDP-4 Ophthalmic Solution (1.0%) | Tear Breakup Time | Day 1 | 3.80 seconds | Standard Deviation 0.99 |
| SDP-4 Ophthalmic Solution (1.0%) | Tear Breakup Time | Day 28 | 1.95 seconds | Standard Deviation 4.069 |
| SDP-4 Ophthalmic Solution (1.0%) | Tear Breakup Time | Day 14 | 1.42 seconds | Standard Deviation 2.85 |