| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| Baseline (Study Eye) - No Cells Seen | - ParticipantsOG00023
- ParticipantsOG00121
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| 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) | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | SF0166High Dose 5.0% BID | SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment. SF0166 Topical Ophthalmic Solution |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline, Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Primary | Change in Intraocular Pressure From Baseline to Week 8 | Mean and standard deviation of change from Baseline in intra-ocular pressure | 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. | Posted | | Mean | Standard Deviation | mmHg | | Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Primary | Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8 | Results are mean plus standard deviation | 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. | Posted | | Mean | Standard Deviation | change from baseline | | Week 2, Week 4, Week 6 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | change from baseline | | Week 2, Week 4, Week 6, and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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