Trial Outcomes & Findings for Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202) (NCT NCT04535947)
NCT ID: NCT04535947
Last Updated: 2022-09-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
56 days
Results posted on
2022-09-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
77
|
|
Overall Study
COMPLETED
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Other reasons not specified
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)
Baseline characteristics by cohort
| Measure |
Vehicle
n=76 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=77 Participants
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.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 15.18 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 14.95 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 15.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color
Blue
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Iris Color
Brown
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Iris Color
Green
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Iris Color
Hazel
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 daysMean 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.
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE) Questionnaire
Screening
|
58.95 units on a scale
Standard Deviation 6.635
|
57.21 units on a scale
Standard Deviation 7.850
|
|
Symptom Assessment in Dry Eye (SANDE) Questionnaire
Day 56
|
-18.80 units on a scale
Standard Deviation 22.288
|
-16.60 units on a scale
Standard Deviation 19.075
|
SECONDARY outcome
Timeframe: 56 daysMean 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.
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Corneal Fluorescein Staining
Screening
|
0.68 units on a scale
Standard Deviation 0.697
|
0.74 units on a scale
Standard Deviation 0.696
|
|
Corneal Fluorescein Staining
Day 14
|
-0.21 units on a scale
Standard Deviation 0.664
|
-0.04 units on a scale
Standard Deviation 0.772
|
|
Corneal Fluorescein Staining
Day 28
|
-0.15 units on a scale
Standard Deviation 0.660
|
-0.22 units on a scale
Standard Deviation 0.809
|
|
Corneal Fluorescein Staining
Day 56
|
-0.15 units on a scale
Standard Deviation 0.725
|
-0.24 units on a scale
Standard Deviation 0.682
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at each visit
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Tear Breakup Time
Day 1
|
3.75 seconds
Standard Deviation 1.104
|
3.80 seconds
Standard Deviation 0.990
|
|
Tear Breakup Time
Day 14
|
1.06 seconds
Standard Deviation 2.570
|
1.42 seconds
Standard Deviation 2.850
|
|
Tear Breakup Time
Day 28
|
2.00 seconds
Standard Deviation 2.596
|
1.95 seconds
Standard Deviation 4.069
|
|
Tear Breakup Time
Day 56
|
1.77 seconds
Standard Deviation 2.865
|
1.80 seconds
Standard Deviation 2.419
|
SECONDARY outcome
Timeframe: 56 daysMean 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.
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Conjunctival Hyperemia
Day 1 Baseline
|
0.80 units on a scale
Standard Deviation 0.833
|
0.91 units on a scale
Standard Deviation 0.948
|
|
Conjunctival Hyperemia
Day 14
|
0.00 units on a scale
Standard Deviation 0.520
|
0.01 units on a scale
Standard Deviation 0.425
|
|
Conjunctival Hyperemia
Day 28
|
-0.07 units on a scale
Standard Deviation 0.608
|
-0.03 units on a scale
Standard Deviation 0.530
|
|
Conjunctival Hyperemia
Day 56
|
0.03 units on a scale
Standard Deviation 0.604
|
-0.06 units on a scale
Standard Deviation 0.554
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)
|
-7.89 units on a scale
Standard Deviation 22.985
|
-17.06 units on a scale
Standard Deviation 23.356
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)
|
-12.10 units on a scale
Standard Deviation 21.195
|
-13.18 units on a scale
Standard Deviation 22.283
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)
|
-17.97 units on a scale
Standard Deviation 24.768
|
-18.38 units on a scale
Standard Deviation 20.921
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)
|
-6.94 units on a scale
Standard Deviation 21.200
|
-6.47 units on a scale
Standard Deviation 23.400
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)
|
-6.17 units on a scale
Standard Deviation 20.025
|
-8.11 units on a scale
Standard Deviation 20.654
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)
|
-6.94 units on a scale
Standard Deviation 20.567
|
-10.58 units on a scale
Standard Deviation 20.031
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)
|
-13.81 units on a scale
Standard Deviation 24.411
|
-9.75 units on a scale
Standard Deviation 22.890
|
SECONDARY outcome
Timeframe: 56 daysMean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Outcome measures
| Measure |
Vehicle
n=72 Participants
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=72 Participants
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.
|
|---|---|---|
|
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)
|
-12.69 units on a scale
Standard Deviation 21.512
|
-10.43 units on a scale
Standard Deviation 22.143
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SDP-4 Ophthalmic Solution (1.0%)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle
n=76 participants at risk
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=77 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Detached Retina
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
Other adverse events
| Measure |
Vehicle
n=76 participants at risk
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.
|
SDP-4 Ophthalmic Solution (1.0%)
n=77 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Eye Pain
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
General disorders
Installation Site Pain
|
6.6%
5/76 • Number of events 10 • 56 days
|
5.2%
4/77 • Number of events 8 • 56 days
|
|
Eye disorders
Blepharitis
|
1.3%
1/76 • Number of events 2 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 2 • 56 days
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
Eye disorders
Eyelid Oedema
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
Eye disorders
Vision Blurred
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/76 • 56 days
|
1.3%
1/77 • Number of events 1 • 56 days
|
|
General disorders
Installation Site Discomfort
|
2.6%
2/76 • Number of events 4 • 56 days
|
1.3%
1/77 • Number of events 2 • 56 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information concerning SDP-4 and the operations of Silk Technologies, such as patent applications, formulas, manufacturing processes, basic scientific data or formulation information not previously published, are considered CONFIDENTIAL and shall remain the sole property of Silk Technologies. The Investigator agrees to use this information only in accomplishing this study and will not use it for other purposes without the written consent of Silk Technologies
- Publication restrictions are in place
Restriction type: OTHER