Trial Outcomes & Findings for Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD) (NCT NCT02914639)
NCT ID: NCT02914639
Last Updated: 2023-06-07
Results Overview
Number and percentage of subjects with no red blood cell counts in the anterior chamber
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline, Week 2, Week 4, Week 6 and Week 8
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
SF0166 Low Dose 2.5% BID
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
SF0166 Low Dose 2.5% BID
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
77.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Iris Color
Blue
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Iris Color
Brown
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Iris Color
Green
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Iris Color
Hazel
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Iris Color
Gray
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with no red blood cell counts in the anterior chamber
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) - No Cells Seen
|
23 Participants
|
21 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) - No Cells Seen
|
23 Participants
|
21 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) - No Cells Seen
|
23 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) - No Cells Seen
|
23 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) - No Cells Seen
|
23 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) - No Cells Seen
|
23 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) - No Cells Seen
|
23 Participants
|
19 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) - No Cells Seen
|
23 Participants
|
19 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) - No Cells Seen
|
23 Participants
|
19 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) - No Cells Seen
|
23 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe)
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · None
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · None
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · None
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · None
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · None
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · None
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · None
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · None
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · None
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · None
|
23 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with absence of hyphema
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with absence of bulbar conjunctival injection
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with absence of erythema
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with absence of edema
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) - Absent
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) - Absent
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) - Absent
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) - Absent
|
23 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with any lens opacity
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Any opacity in the lens
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · No opacity in the lens
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Any opacity in the lens
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · No opacity in the lens
|
12 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Any opacity in the lens
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · No opacity in the lens
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Any opacity in the lens
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · No opacity in the lens
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Any opacity in the lens
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · No opacity in the lens
|
11 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Any opacity in the lens
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · No opacity in the lens
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Any opacity in the lens
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · No opacity in the lens
|
10 Participants
|
11 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Any opacity in the lens
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · No opacity in the lens
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Any opacity in the lens
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · No opacity in the lens
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Any opacity in the lens
|
12 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · No opacity in the lens
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with abnormal findings in the optic nerve
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
21 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
21 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
21 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
21 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with abnormal findings in the vitreous
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
16 Participants
|
8 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
15 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
8 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
15 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
8 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
15 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
8 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
15 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
15 Participants
|
8 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
8 Participants
|
11 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
8 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with abnormal findings in the fundus
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
19 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
19 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with abnormal findings in the macula/choroid
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
22 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with abnormal findings in the retinal vessels
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
20 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
22 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
20 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
22 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
22 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
20 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
22 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
22 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the low dose group 2.5% group did not have values recorded at Baseline or Week 2 for either the study eye or the fellow eye. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Number and percentage of subjects with specified Cup:Disc ratio in the range from 0.1 to 0.9 with the higher number being worse
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.75
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.85
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.10
|
1 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.20
|
8 Participants
|
8 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.30
|
8 Participants
|
8 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.40
|
2 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.75
|
0 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.85
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.20
|
7 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.30
|
8 Participants
|
7 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.40
|
1 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.75
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.85
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.10
|
1 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.20
|
8 Participants
|
8 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.30
|
8 Participants
|
7 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.40
|
2 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.75
|
0 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.85
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.20
|
7 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.30
|
8 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.40
|
1 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.70
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.75
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.85
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.10
|
1 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.20
|
8 Participants
|
8 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.30
|
9 Participants
|
7 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.40
|
2 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.75
|
0 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.85
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.20
|
7 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.30
|
9 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.40
|
1 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.75
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.85
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.10
|
1 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.20
|
8 Participants
|
9 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.30
|
9 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.40
|
2 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.75
|
0 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.85
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.20
|
7 Participants
|
7 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.30
|
9 Participants
|
5 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.40
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.75
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.85
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.10
|
1 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.20
|
8 Participants
|
9 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.30
|
9 Participants
|
6 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.40
|
2 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.75
|
0 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.85
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.90
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.10
|
1 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.20
|
7 Participants
|
8 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.30
|
9 Participants
|
5 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.40
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.70
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.90
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 4. Angiograms were not obtained for two participants in the high dose 5.0% group at Week 4.
Number and percentage of subjects with abnormal fluorescein angiogram findings
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Baseline (Study Eye) · Abnormal
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Baseline (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Baseline (Fellow Eye) · Abnormal
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Baseline (Fellow Eye) · Normal
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Week 4 (Study Eye) · Abnormal
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Week 4 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Week 4 (Fellow Eye) · Abnormal
|
20 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Week 4 (Fellow Eye) · Normal
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 2, Week 4, Week 6 and Week 8Population: The analysis population includes all randomized participants, 23 in the low dose 2.5% group and 21 in the high dose 5.0% group. One participant in the high dose 5.0% group discontinued prior to Week 2 and one participant in the high dose group discontinued prior to Week 6.
Mean and standard deviation of change from Baseline in intra-ocular pressure
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=23 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 2
|
0.1 mmHg
Standard Deviation 3.2
|
0.5 mmHg
Standard Deviation 2.8
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 2
|
0.3 mmHg
Standard Deviation 3.1
|
1.4 mmHg
Standard Deviation 2.6
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 4
|
-1.0 mmHg
Standard Deviation 3.0
|
0.5 mmHg
Standard Deviation 3.5
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 4
|
-0.7 mmHg
Standard Deviation 4.1
|
0.7 mmHg
Standard Deviation 2.6
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 6
|
-0.4 mmHg
Standard Deviation 3.2
|
0.9 mmHg
Standard Deviation 3.4
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 6
|
-0.7 mmHg
Standard Deviation 3.3
|
0.2 mmHg
Standard Deviation 3.1
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 8
|
-0.5 mmHg
Standard Deviation 4.0
|
0.4 mmHg
Standard Deviation 3.3
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 8
|
0.3 mmHg
Standard Deviation 3.7
|
0.6 mmHg
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Week 2, Week 4, Week 6 and Week 8Population: The analysis population is the per protocol population with 22 participants in the low dose 2.5% and 19 participants in the high dose 5.0% group at Baseline. Prior to Week 6, two participants in the low dose 2.5% group and three in the high dose 5.0% group were given rescue medication; the data excluded for Week 6 and Week 8. Three participants in the high dose 5.0% group were rescued prior to Week 8; the data for Week 8 are excluded.
Results are mean plus standard deviation
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=19 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Change from Baseline at Week 2
|
-1.6 change from baseline
Standard Deviation 36.2
|
3.8 change from baseline
Standard Deviation 25.4
|
|
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Change from Baseline at Week 4
|
-1.3 change from baseline
Standard Deviation 83.0
|
13.8 change from baseline
Standard Deviation 54.0
|
|
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Change from Baseline at Week 6
|
26.1 change from baseline
Standard Deviation 117.0
|
-8.2 change from baseline
Standard Deviation 32.8
|
|
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Change from Baseline at Week 8
|
27.5 change from baseline
Standard Deviation 105.1
|
-6.9 change from baseline
Standard Deviation 35.9
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, and Week 8Population: IThe analysis population is the per protocol population with 22 participants in the low dose 2.5% and 19 participants in the high dose 5.0% group at Baseline. Prior to Week 6, two participants in the low dose 2.5% group and three in the high dose 5.0% group were given rescue medication; the data excluded for Week 6 and Week 8. Three participants in the high dose 5.0% group were rescued prior to Week 8; the data for Week 8 are excluded.
Results are mean plus standard deviation in per protocol population.
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=19 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 2
|
2.8 change from baseline
Standard Deviation 7.1
|
2.8 change from baseline
Standard Deviation 5.0
|
|
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 4
|
2.5 change from baseline
Standard Deviation 6.7
|
1.7 change from baseline
Standard Deviation 6.5
|
|
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 6
|
1.3 change from baseline
Standard Deviation 4.3
|
2.4 change from baseline
Standard Deviation 9.0
|
|
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 8
|
1.0 change from baseline
Standard Deviation 5.4
|
1.9 change from baseline
Standard Deviation 9.4
|
Adverse Events
SF0166 Low Dose 2.5% BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SF0166 High Dose 5.0% BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SF0166 Low Dose 2.5% BID
n=23 participants at risk
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 participants at risk
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
Other adverse events
| Measure |
SF0166 Low Dose 2.5% BID
n=23 participants at risk
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=21 participants at risk
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Eye disorders
Visual acuity reduced
|
8.7%
2/23 • 8 weeks
|
0.00%
0/21 • 8 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • 8 weeks
|
0.00%
0/21 • 8 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • 8 weeks
|
9.5%
2/21 • 8 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/23 • 8 weeks
|
4.8%
1/21 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place