Age-Related Macular Degeneration
Conditions
Brief summary
The primary purpose of this study was to evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD).
Detailed description
This was a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in which 44 eligible subjects with Neovascular Age-related Macular Degeneration (AMD) were randomized to 1 of 2 treatment arms in a 1:1 ratio as follows: SF0166 low dose twice daily (BID) or SF0166 high dose BID. Study subjects administered the randomly assigned treatment for 28 days. There was an additional 28-day post-treatment follow-up period. Study subjects returned for examination every 2 weeks for 8 weeks (2 months).
Interventions
Sponsors
OcuTerra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, 50 years of age or older. 2. Active subfoveal choroidal neovascularization due to Age-related Macular Degeneration (AMD) in the study eye that meet the following criteria: * Total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas * Choroidal neovascularization (CNV) \>50% of lesion area * Intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on optical coherence tomography (OCT) * No atrophy or fibrosis involving the center of the fovea 3. Best-corrected Visual Acuity (BCVA) between 78 and 25 letters, inclusive, in the study eye at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, with BCVA decrement primarily attributable to neovascular Age-related Macular Degeneration (AMD). 4. Treatment naïve (i.e., no previous anti--vascular endothelial growth factor \[VEGF\] treatment in the study eye) or previously treated study eye with adequate washout defined below: 1. Lucentis (ranibizumab): 30-day washout 2. Avastin (bevacizumab): 30-day washout 3. Eylea (aflibercept): 60-day washout 4. Macugen (pegaptanib): 45-day washout 5. Willing and able to return for all study visits. 6. Able to adhere to the study dosing requirements. 7. Understands and signs the written informed consent form.
Exclusion criteria
1. Non-study eye best corrected visual acuity (BCVA) worse than 20 letters at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. 2. Choroidal neovascularization (CNV) in the study eye secondary to other causes (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis). 3. Previous macular laser photocoagulation or ocular photodynamic therapy in the study eye. 4. Media opacities or abnormalities in the study eye that would preclude visualization of the retina. 5. Other retinal pathologies in the study eye that would interfere with vision. 6. Retinal pigment epithelial (RPE) tear in the study eye. 7. Significant epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined by optical coherence tomography (OCT) results. 8. Uncontrolled glaucoma or ocular hypertension in the study eye defined as an Intraocular Pressure (IOP) \>25 millimeter of mercury (mmHg) regardless of concomitant treatment with IOP lowering medications. 9. Uncontrolled hypertension defined as systolic \>180 mmHg or \>160 mmHg on 2 consecutive measurements (during the same visit) or diastolic \>100 mmHg on optimal medical regimen 10. Previous pars plana vitrectomy in the study eye. 11. Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment. 12. Yttrium aluminium garnet (YAG) laser treatment in the study eye within 30 days (1 month) prior to study enrollment. 13. Intravitreal/periocular/topical ocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment. 14. Concomitant use any topical ophthalmic medications in the study eye, including dry eye or glaucoma medications, unless on a stable dose for at least 90 days (3 months) prior to study enrollment and expected to stay on stable dose throughout study participation. Artificial tears are allowed. 15. Chronic or recurrent uveitis in the study eye. 16. Ongoing ocular infection or inflammation in either eye. 17. A history of cataract surgery complicated by vitreous loss in the study eye. 18. Congenital eye malformations in the study eye. 19. A history of penetrating ocular trauma in the study eye. 20. Mentally handicapped. 21. Females of childbearing potential (i.e., who are not postmenopausal for at least 1 year or surgically sterile for at least 6 weeks prior to Visit 1 - Screening/Randomization) who are lactating, or who are pregnant as determined by a positive urine pregnancy test (UPT) at Visit 1 - Screening/Randomization. Women of childbearing potential must agree to use acceptable methods of birth control throughout the study. Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral/implantable/injectable or contraceptives, sexual abstinence, double barrier method, or vasectomized partner. 22. Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization. 23. Contraindication to the study medications or fluorescein dye. 24. Other ocular pathologies that in the Investigator's opinion would interfere with vision in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8 | Week 2, Week 4, Week 6 and Week 8 | Results are mean plus standard deviation |
| Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with no red blood cell counts in the anterior chamber |
| Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe) |
| Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with absence of hyphema |
| Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with absence of bulbar conjunctival injection |
| Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with absence of erythema |
| Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with absence of edema |
| Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with any lens opacity |
| Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with abnormal findings in the optic nerve |
| Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with abnormal findings in the vitreous |
| Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with abnormal findings in the fundus |
| Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with abnormal findings in the macula/choroid |
| Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | Number and percentage of subjects with abnormal findings in the retinal vessels |
| Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline, Week 2, Week 4, Week 6 and Week 8 | 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 |
| Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline and Week 4 | Number and percentage of subjects with abnormal fluorescein angiogram findings |
| Change in Intraocular Pressure From Baseline to Week 8 | Week 2, Week 4, Week 6 and Week 8 | Mean and standard deviation of change from Baseline in intra-ocular pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8 | Week 2, Week 4, Week 6, and Week 8 | Results are mean plus standard deviation in per protocol population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| 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 | 21 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | SF0166 Low Dose 2.5% BID | SF0166 High Dose 5.0% BID | Total |
|---|---|---|---|
| Age, Continuous | 78.1 years STANDARD_DEVIATION 8.3 | 77.3 years STANDARD_DEVIATION 6.1 | 77.7 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 18 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Blue | 10 Participants | 10 Participants | 20 Participants |
| Iris Color Brown | 9 Participants | 9 Participants | 18 Participants |
| Iris Color Gray | 0 Participants | 2 Participants | 2 Participants |
| Iris Color Green | 2 Participants | 0 Participants | 2 Participants |
| Iris Color Hazel | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 20 Participants |
| Sex: Female, Male Male | 16 Participants | 8 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 21 |
| other Total, other adverse events | 2 / 23 | 10 / 21 |
| serious Total, serious adverse events | 0 / 23 | 1 / 21 |
Outcome results
Primary
Change in Intraocular Pressure From Baseline to Week 8
Mean and standard deviation of change from Baseline in intra-ocular pressure
Time frame: Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Study Eye at Week 4 | -1.0 mmHg | Standard Deviation 3 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Study Eye at Week 8 | -0.5 mmHg | Standard Deviation 4 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Non-Study Eye at Week 8 | 0.6 mmHg | Standard Deviation 3 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Study Eye at Week 2 | 0.5 mmHg | Standard Deviation 2.8 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Study Eye at Week 6 | 0.9 mmHg | Standard Deviation 3.4 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Non-Study Eye at Week 2 | 1.4 mmHg | Standard Deviation 2.6 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Study Eye at Week 8 | 0.4 mmHg | Standard Deviation 3.3 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Study Eye at Week 4 | 0.5 mmHg | Standard Deviation 3.5 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Non-Study Eye at Week 6 | 0.2 mmHg | Standard Deviation 3.1 |
| SF0166 High Dose 5.0% BID | Change in Intraocular Pressure From Baseline to Week 8 | Change from Baseline in Non-Study Eye at Week 4 | 0.7 mmHg | Standard Deviation 2.6 |
Primary
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Results are mean plus standard deviation
Time frame: Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 High Dose 5.0% BID | Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8 | Change from Baseline at Week 8 | -6.9 change from baseline | Standard Deviation 35.9 |
| SF0166 High Dose 5.0% BID | Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8 | Change from Baseline at Week 2 | 3.8 change from baseline | Standard Deviation 25.4 |
| SF0166 High Dose 5.0% BID | Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8 | Change from Baseline at Week 6 | -8.2 change from baseline | Standard Deviation 32.8 |
| SF0166 High Dose 5.0% BID | Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8 | Change from Baseline at Week 4 | 13.8 change from baseline | Standard Deviation 54 |
Primary
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
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
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.30 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.40 | 2 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.50 | 3 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.75 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.30 | 9 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.40 | 2 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.85 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.75 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.30 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.70 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.20 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.30 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.40 | 2 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.50 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.75 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.85 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.20 | 7 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.30 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.40 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.50 | 3 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.75 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.20 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.50 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.75 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.85 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.20 | 7 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.40 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.50 | 3 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.75 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.20 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.30 | 9 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.40 | 2 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.50 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.75 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.85 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.20 | 7 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.30 | 9 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.40 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.50 | 3 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.75 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.30 | 9 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.20 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.30 | 9 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.40 | 2 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.50 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.40 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.75 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.85 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.20 | 7 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.20 | 8 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.50 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.70 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.75 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.90 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.10 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.20 | 7 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.30 | 9 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.40 | 1 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.50 | 3 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 Low Dose 2.5% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.90 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.50 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.30 | 7 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.20 | 8 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.40 | 3 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.40 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.50 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.30 | 7 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.20 | 8 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.40 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.30 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.75 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.50 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.50 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.20 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.75 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.75 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.75 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.50 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.10 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.20 | 8 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.30 | 8 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.40 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.50 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.10 | 3 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.75 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.20 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.30 | 5 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.30 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.10 | 3 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.10 | 3 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.20 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.40 | 4 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.30 | 7 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.75 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.40 | 4 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.50 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.50 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.20 | 7 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.75 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.75 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.10 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.20 | 8 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.40 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.50 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.70 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.40 | 3 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.75 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.10 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.10 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.10 | 3 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.20 | 9 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.30 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.10 | 2 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.40 | 4 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.30 | 6 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.50 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | 0.30 | 5 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.75 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.85 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | 0.40 | 1 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | 0.90 | 0 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | 0.20 | 9 Participants |
| SF0166 High Dose 5.0% BID | Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | 0.10 | 2 Participants |
Primary
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Number and percentage of subjects with abnormal fluorescein angiogram findings
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Study Eye) | Normal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Fellow Eye) | Normal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Fellow Eye) | Abnormal | 20 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Study Eye) | Abnormal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Fellow Eye) | Abnormal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Study Eye) | Normal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Fellow Eye) | Normal | 3 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Study Eye) | Abnormal | 23 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Fellow Eye) | Normal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Study Eye) | Abnormal | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Study Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Fellow Eye) | Abnormal | 15 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Study Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Fellow Eye) | Abnormal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Baseline (Fellow Eye) | Normal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline | Week 4 (Study Eye) | Abnormal | 18 Participants |
Primary
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the fundus
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 4 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 16 Participants |
Primary
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the macula/choroid
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 22 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 0 Participants |
Primary
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the optic nerve
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 2 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 21 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 2 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 21 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 2 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 2 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 21 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 21 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 2 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 2 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 1 Participants |
Primary
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the retinal vessels
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 20 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 3 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 20 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 3 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 20 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 3 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 19 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 4 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 18 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 3 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 17 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 16 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 3 Participants |
Primary
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the vitreous
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 16 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 7 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 8 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 15 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 8 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Abnormal | 11 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Normal | 7 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Normal | 6 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Study Eye) | Abnormal | 13 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Abnormal | 13 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Normal | 8 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Abnormal | 14 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Study Eye) | Abnormal | 13 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Abnormal | 12 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Normal | 6 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Normal | 7 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Abnormal | 15 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Study Eye) | Normal | 8 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Normal | 6 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Study Eye) | Abnormal | 12 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Abnormal | 14 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Normal | 7 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Normal | 7 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Normal | 6 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8 | Week 4 (Study Eye) | Abnormal | 13 Participants |
Primary
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of bulbar conjunctival injection
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 20 Participants |
Primary
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of edema
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 23 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 20 Participants |
Primary
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of erythema
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 23 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 20 Participants |
Primary
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of hyphema
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 23 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - Absent | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - Absent | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - Absent | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - Absent | 20 Participants |
Primary
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with any lens opacity
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 High Dose 5.0% BID | 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 |
| SF0166 High Dose 5.0% BID | 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 | 8 Participants |
| SF0166 High Dose 5.0% BID | 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 | 7 Participants |
| SF0166 High Dose 5.0% BID | 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 | 14 Participants |
| SF0166 High Dose 5.0% BID | 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 | 8 Participants |
| SF0166 High Dose 5.0% BID | 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 | 13 Participants |
| SF0166 High Dose 5.0% BID | 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 | 7 Participants |
| SF0166 High Dose 5.0% BID | 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 | 13 Participants |
| SF0166 High Dose 5.0% BID | 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 | 8 Participants |
| SF0166 High Dose 5.0% BID | 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 |
| SF0166 High Dose 5.0% BID | 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 | 7 Participants |
| SF0166 High Dose 5.0% BID | 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 | 13 Participants |
| SF0166 High Dose 5.0% BID | 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 | 8 Participants |
| SF0166 High Dose 5.0% BID | 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 |
| SF0166 High Dose 5.0% BID | 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 | 8 Participants |
| SF0166 High Dose 5.0% BID | 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 | 11 Participants |
| SF0166 High Dose 5.0% BID | 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 | 9 Participants |
| SF0166 High Dose 5.0% BID | 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 | 10 Participants |
| SF0166 High Dose 5.0% BID | 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 | 7 Participants |
| SF0166 High Dose 5.0% BID | 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 | 12 Participants |
Primary
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe)
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) | None | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) | None | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Mild | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Mild | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) | Mild | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | None | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | None | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) | Mild | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) | None | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) | None | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) | Mild | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Mild | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) | Mild | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Mild | 1 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) | None | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | None | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Mild | 0 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) | None | 22 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | None | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) | Mild | 1 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | None | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) | None | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) | None | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) | None | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) | None | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) | None | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) | None | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) | None | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) | None | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) | None | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) | Mild | 0 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) | Mild | 0 Participants |
Primary
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with no red blood cell counts in the anterior chamber
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SF0166 Low Dose 2.5% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - No Cells Seen | 23 Participants |
| SF0166 Low Dose 2.5% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - No Cells Seen | 23 Participants |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Fellow Eye) - No Cells Seen | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Study Eye) - No Cells Seen | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Fellow Eye) - No Cells Seen | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Baseline (Fellow Eye) - No Cells Seen | 21 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Fellow Eye) - No Cells Seen | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Study Eye) - No Cells Seen | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 6 (Study Eye) - No Cells Seen | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 2 (Fellow Eye) - No Cells Seen | 20 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 8 (Study Eye) - No Cells Seen | 19 Participants |
| SF0166 High Dose 5.0% BID | Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 | Week 4 (Study Eye) - No Cells Seen | 20 Participants |
Secondary
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Results are mean plus standard deviation in per protocol population.
Time frame: Week 2, Week 4, Week 6, and Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 Low Dose 2.5% BID | 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 |
| SF0166 High Dose 5.0% BID | Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8 | Change from Baseline at Week 8 | 1.9 change from baseline | Standard Deviation 9.4 |
| SF0166 High Dose 5.0% BID | Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8 | Change from Baseline at Week 4 | 1.7 change from baseline | Standard Deviation 6.5 |
| SF0166 High Dose 5.0% BID | Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8 | Change from Baseline at Week 6 | 2.4 change from baseline | Standard Deviation 9 |
| SF0166 High Dose 5.0% BID | 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 5 |