Trial Outcomes & Findings for Evaluation of Efficacy and Safety of SDN-037 (NCT NCT03426267)
NCT ID: NCT03426267
Last Updated: 2021-05-17
Results Overview
Grade Cell Count 0 0 1. 1-10 2. 11-20 3. 21-50 4. \> 50 ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \>0 at Day 15 visit was considered a failure (or non-responder)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
Day 15
Results posted on
2021-05-17
Participant Flow
Participant milestones
| Measure |
SDN-037
dosage: SDN-037
dosage form: solution
frequency of administration: twice daily
|
Vehicle
dosage: Placebo
dosage form: solution
frequency of administration: twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
162
|
|
Overall Study
Modified Intent-to-Treat Population
|
154
|
144
|
|
Overall Study
COMPLETED
|
142
|
90
|
|
Overall Study
NOT COMPLETED
|
21
|
72
|
Reasons for withdrawal
| Measure |
SDN-037
dosage: SDN-037
dosage form: solution
frequency of administration: twice daily
|
Vehicle
dosage: Placebo
dosage form: solution
frequency of administration: twice daily
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Adverse Event
|
9
|
27
|
|
Overall Study
Prohibited Treatment Intake
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
25
|
|
Overall Study
other
|
3
|
0
|
Baseline Characteristics
Evaluation of Efficacy and Safety of SDN-037
Baseline characteristics by cohort
| Measure |
SDN-037
n=154 Participants
SDN-037: twice daily
|
Vehicle
n=144 Participants
Placebo: twice daily
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 8.61 • n=93 Participants
|
68.3 years
STANDARD_DEVIATION 8.94 • n=4 Participants
|
68.3 years
STANDARD_DEVIATION 8.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
178 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
216 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
224 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Modified Intent-to-Treat Population
Grade Cell Count 0 0 1. 1-10 2. 11-20 3. 21-50 4. \> 50 ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \>0 at Day 15 visit was considered a failure (or non-responder)
Outcome measures
| Measure |
SDN-037
n=154 Participants
SDN-037: twice daily
|
Vehicle
n=144 Participants
Placebo: twice daily
|
|---|---|---|
|
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
|
96 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: Modified Intent-To-Treat Population
Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent \>100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity.
Outcome measures
| Measure |
SDN-037
n=154 Participants
SDN-037: twice daily
|
Vehicle
n=144 Participants
Placebo: twice daily
|
|---|---|---|
|
Subjects Who Achieve a Pain Score of 0 at Day 15
|
151 Participants
|
106 Participants
|
Adverse Events
SDN-037
Serious events: 2 serious events
Other events: 87 other events
Deaths: 0 deaths
Vehicle
Serious events: 2 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SDN-037
n=154 participants at risk
SDN-037: twice daily
|
Vehicle
n=144 participants at risk
Placebo: twice daily
|
|---|---|---|
|
Eye disorders
Rhegmatogenous Retinal Detachment In Study Eye
|
0.00%
0/154 • Up to 6 visits over a period of 22 to 36 days
|
0.69%
1/144 • Number of events 1 • Up to 6 visits over a period of 22 to 36 days
|
|
Infections and infestations
Left Foot Infection Secondary To Trauma
|
0.65%
1/154 • Number of events 1 • Up to 6 visits over a period of 22 to 36 days
|
0.00%
0/144 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Cystoid Macula Edema
|
0.65%
1/154 • Number of events 2 • Up to 6 visits over a period of 22 to 36 days
|
0.69%
1/144 • Number of events 3 • Up to 6 visits over a period of 22 to 36 days
|
Other adverse events
| Measure |
SDN-037
n=154 participants at risk
SDN-037: twice daily
|
Vehicle
n=144 participants at risk
Placebo: twice daily
|
|---|---|---|
|
Eye disorders
Anterior chamber cell
|
16.9%
26/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
24.3%
35/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Anterior chamber flare
|
9.7%
15/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
21.5%
31/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Visual acuity reduced
|
9.1%
14/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
20.8%
30/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Conjunctival hyperaemia
|
3.2%
5/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
15.3%
22/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Corneal oedema
|
3.9%
6/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
13.9%
20/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Eye pain
|
6.5%
10/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
9.7%
14/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Eye disorders
Photophobia
|
3.9%
6/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
6.9%
10/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
|
Investigations
Intraocular pressure increased
|
11.0%
17/154 • Number of events 87 • Up to 6 visits over a period of 22 to 36 days
|
4.9%
7/144 • Number of events 96 • Up to 6 visits over a period of 22 to 36 days
|
Additional Information
Head-Clinical Development
Sun Pharma Advanced Research Company Limited
Phone: 912266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER