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This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS-01 | Experimental | 1 drop of OCS-01 (Dexamethasone ophthalmic suspension 1.5% [15 mg/mL]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye. |
|
| Vehicle | Placebo Comparator | 1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS-01 | Drug | Dexamethasone ophthalmic suspension, 1.5% |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Anterior Chamber Cells at Visit 6. | Day 15 | |
| Absence of Ocular Pain at Visit 4. | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oculis Site 16 | Chandler | Arizona | 85224 | United States | ||
| Oculis Site 28 |
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| ID | Title | Description |
|---|---|---|
| FG000 | OCS-01 | 1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye. |
| FG001 | Vehicle | 1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2022 | Jun 24, 2025 |
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| Drug |
Vehicle |
|
| Phoenix |
| Arizona |
| 85003 |
| United States |
| Oculis Site 8 | Fayetteville | Arkansas | 72704 | United States |
| Oculis Site 9 | Inglewood | California | 90301 | United States |
| Oculis Site 23 | Newport Beach | California | 92663 | United States |
| Oculis Site 26 | Petaluma | California | 94954 | United States |
| Oculis Site 24 | San Pedro | California | 90731 | United States |
| Oculis Site 22 | Westminster | California | 92683 | United States |
| Oculis Site 11 | Fort Collins | Colorado | 80528 | United States |
| Oculis Site 12 | Tamarac | Florida | 33321 | United States |
| Oculis Site 17 | Morrow | Georgia | 30260 | United States |
| Oculis Site 20 | Louisville | Kentucky | 40206 | United States |
| Oculis Site 5 | St Louis | Missouri | 63128 | United States |
| Oculis Site 3 | Washington | Missouri | 63090 | United States |
| Oculis Site 13 | Kinston | North Carolina | 28501 | United States |
| Oculis Site 6 | Brecksville | Ohio | 44141 | United States |
| Oculis Site 14 | Cincinnati | Ohio | 45242 | United States |
| Oculis Site 25 | Eugene | Oregon | 97401 | United States |
| Oculis Site 7 | Kingston | Pennsylvania | 18704 | United States |
| Oculis Site 4 | Austin | Texas | 78731 | United States |
| Oculis Site 10 | Houston | Texas | 77025 | United States |
| Oculis Site 2 | San Antonio | Texas | 78229 | United States |
| Oculis Site 31 | San Antonio | Texas | 78229 | United States |
| Oculis Site 27 | Salt Lake City | Utah | 84032 | United States |
| Oculis Site 30 | Lynchburg | Virginia | 24502 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) consists of all randomized subjects who were analyzed under the treatment to which they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | OCS-01 | 1 drop of OCS-01 in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye. |
| BG001 | Vehicle | 1 drop of vehicle in the study eye once QD for 14 days, beginning 1-day post-surgery in the study eye. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absence of Anterior Chamber Cells at Visit 6. | FAS | Posted | Number | percentage of study eyes | Day 15 | study eye | study eye |
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| Primary | Absence of Ocular Pain at Visit 4. | FAS | Posted | Number | percentage of study eyes | Day 4 | study eye | study eye |
|
|
From first dose until Day 90
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCS-01 | 1 drop of OCS-01 in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye. | 0 | 119 | 0 | 119 | 2 | 119 |
| EG001 | Vehicle | 1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye. | 0 | 122 | 1 | 122 | 8 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | MedDRA (25.0) | Systematic Assessment | Study eye |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Klier, M.D., M.S., M.P.H, Chief Development Officer | OCULIS Operations SàrI | +41 21 711 3970 | info@oculis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2023 | Jun 24, 2025 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| study eye |
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