Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (NCT NCT03889886)
NCT ID: NCT03889886
Last Updated: 2022-09-02
Results Overview
Mean change from baseline in total SANDE score at Visit 7/Day 84 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
305 participants
Primary outcome timeframe
84 days
Results posted on
2022-09-02
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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
77
|
76
|
76
|
|
Overall Study
COMPLETED
|
76
|
76
|
75
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
7
|
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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Overall Study
Other
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
6
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=77 Participants
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=76 Participants
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=76 Participants
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
60.5 years
STANDARD_DEVIATION 15.86 • n=107 Participants
|
60.1 years
STANDARD_DEVIATION 15.58 • n=206 Participants
|
61.5 years
STANDARD_DEVIATION 13.68 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 15.08 • n=31 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
245 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
263 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
257 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 84 daysMean change from baseline in total SANDE score at Visit 7/Day 84 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=76 Participants
Vehicle
Vehicle: Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 Participants
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 Participants
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 Participants
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Symptom Assessment in Dry Eye (SANDE) Questionnaire
|
-25.66 units on a scale
Standard Deviation 26.685
|
-25.14 units on a scale
Standard Deviation 25.076
|
-29.95 units on a scale
Standard Deviation 24.883
|
-24.81 units on a scale
Standard Deviation 26.685
|
SECONDARY outcome
Timeframe: 84 daysMean change from baseline at each visit
Outcome measures
| 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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 Participants
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 Participants
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 Participants
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Tear Breakup Time
Day 7
|
0.95 seconds
Standard Deviation 1.816
|
1.29 seconds
Standard Deviation 4.433
|
1.21 seconds
Standard Deviation 2.993
|
0.80 seconds
Standard Deviation 3.085
|
|
Tear Breakup Time
Day 14
|
1.08 seconds
Standard Deviation 3.430
|
1.15 seconds
Standard Deviation 1.487
|
1.37 seconds
Standard Deviation 2.735
|
1.09 seconds
Standard Deviation 2.175
|
|
Tear Breakup Time
Day 28
|
1.00 seconds
Standard Deviation 2.246
|
1.92 seconds
Standard Deviation 4.135
|
2.20 seconds
Standard Deviation 4.498
|
1.63 seconds
Standard Deviation 3.750
|
|
Tear Breakup Time
Day 56
|
1.18 seconds
Standard Deviation 2.728
|
1.38 seconds
Standard Deviation 2.020
|
2.13 seconds
Standard Deviation 4.123
|
1.29 seconds
Standard Deviation 1.878
|
|
Tear Breakup Time
Day 84
|
1.44 seconds
Standard Deviation 3.213
|
1.44 seconds
Standard Deviation 2.097
|
1.49 seconds
Standard Deviation 3.177
|
1.09 seconds
Standard Deviation 1.693
|
SECONDARY outcome
Timeframe: 84 daysMean change from baseline at Visit7/Day 84
Outcome measures
| 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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 Participants
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 Participants
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 Participants
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Anesthetized Schirmer's Test
|
2.53 millimeter
Standard Deviation 5.582
|
2.95 millimeter
Standard Deviation 6.190
|
1.89 millimeter
Standard Deviation 4.706
|
3.75 millimeter
Standard Deviation 5.699
|
SECONDARY outcome
Timeframe: 84 daysMean 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=76 Participants
Vehicle
Vehicle: Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 Participants
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 Participants
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 Participants
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Conjunctival Hyperemia
Day 7
|
-0.6 units on a scale
Standard Deviation 1.87
|
-0.7 units on a scale
Standard Deviation 1.82
|
-0.9 units on a scale
Standard Deviation 1.91
|
-0.6 units on a scale
Standard Deviation 2.19
|
|
Conjunctival Hyperemia
Day 14
|
-0.6 units on a scale
Standard Deviation 2.28
|
-0.8 units on a scale
Standard Deviation 1.78
|
-0.6 units on a scale
Standard Deviation 2.28
|
-0.6 units on a scale
Standard Deviation 1.97
|
|
Conjunctival Hyperemia
Day 28
|
-0.8 units on a scale
Standard Deviation 2.70
|
-0.8 units on a scale
Standard Deviation 1.98
|
-0.9 units on a scale
Standard Deviation 2.14
|
-0.6 units on a scale
Standard Deviation 2.59
|
|
Conjunctival Hyperemia
Day 56
|
-0.9 units on a scale
Standard Deviation 2.30
|
-0.6 units on a scale
Standard Deviation 1.99
|
-0.7 units on a scale
Standard Deviation 2.48
|
-0.7 units on a scale
Standard Deviation 2.55
|
|
Conjunctival Hyperemia
Day 84
|
-0.6 units on a scale
Standard Deviation 2.35
|
-0.8 units on a scale
Standard Deviation 2.60
|
-0.3 units on a scale
Standard Deviation 2.45
|
-0.6 units on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: 84 daysMean 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=76 Participants
Vehicle
Vehicle: Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 Participants
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 Participants
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 Participants
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Corneal Fluoroscein Staining
Day 7
|
-0.2 units on a scale
Standard Deviation 2.15
|
-1.4 units on a scale
Standard Deviation 2.03
|
-0.9 units on a scale
Standard Deviation 2.16
|
-1.4 units on a scale
Standard Deviation 2.00
|
|
Corneal Fluoroscein Staining
Day 14
|
-0.5 units on a scale
Standard Deviation 2.02
|
-1.2 units on a scale
Standard Deviation 2.21
|
-1.1 units on a scale
Standard Deviation 1.99
|
-1.3 units on a scale
Standard Deviation 2.11
|
|
Corneal Fluoroscein Staining
Day 28
|
-0.9 units on a scale
Standard Deviation 2.55
|
-1.5 units on a scale
Standard Deviation 2.43
|
-1.3 units on a scale
Standard Deviation 1.97
|
-1.2 units on a scale
Standard Deviation 2.15
|
|
Corneal Fluoroscein Staining
Day 56
|
-1.2 units on a scale
Standard Deviation 2.36
|
-1.3 units on a scale
Standard Deviation 2.07
|
-0.9 units on a scale
Standard Deviation 2.53
|
-1.6 units on a scale
Standard Deviation 1.96
|
|
Corneal Fluoroscein Staining
Day 84
|
-0.8 units on a scale
Standard Deviation 1.96
|
-1.3 units on a scale
Standard Deviation 2.45
|
-1.2 units on a scale
Standard Deviation 2.99
|
-1.4 units on a scale
Standard Deviation 2.29
|
Adverse Events
Vehicle
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
SDP-4 Ophthalmic Solution (0.1%)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SDP-4 Ophthalmic Solution (1.0%)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SDP-4 Ophthalmic Solution (3.0%)
Serious events: 0 serious events
Other events: 23 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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 participants at risk
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 participants at risk
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 participants at risk
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diverticulitis
|
1.3%
1/76 • Number of events 1 • 84 days
|
0.00%
0/76 • 84 days
|
0.00%
0/75 • 84 days
|
0.00%
0/69 • 84 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 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (0.1%)
n=76 participants at risk
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (1.0%)
n=75 participants at risk
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
SDP-4 Ophthalmic Solution (3.0%)
n=69 participants at risk
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%): Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
|
|---|---|---|---|---|
|
Eye disorders
Eye Disorders
|
10.5%
8/76 • Number of events 11 • 84 days
|
11.8%
9/76 • Number of events 13 • 84 days
|
12.0%
9/75 • Number of events 12 • 84 days
|
23.2%
16/69 • Number of events 28 • 84 days
|
|
General disorders
General Disorders and administration site conditions
|
7.9%
6/76 • Number of events 6 • 84 days
|
6.6%
5/76 • Number of events 5 • 84 days
|
13.3%
10/75 • Number of events 10 • 84 days
|
8.7%
6/69 • Number of events 7 • 84 days
|
|
Investigations
Investigations
|
2.6%
2/76 • Number of events 2 • 84 days
|
1.3%
1/76 • Number of events 2 • 84 days
|
0.00%
0/75 • 84 days
|
1.4%
1/69 • Number of events 1 • 84 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