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The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDN-037 | Experimental |
| |
| vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDN-037 | Drug | twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | Grade Cell Count 0 0
ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of >0 at Day 15 visit was considered a failure (or non-responder) | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Who Achieve a Pain Score of 0 at Day 15 | Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent >100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity. | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 13 | Chandler | Arizona | 85224 | United States | ||
| SPARC Site 14 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SDN-037 | dosage: SDN-037 dosage form: solution frequency of administration: twice daily |
| FG001 | Vehicle | dosage: Placebo dosage form: solution frequency of administration: twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Aug 2, 2019 | Mar 3, 2021 |
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| Drug |
twice daily |
|
| Mesa |
| Arizona |
| 85208 |
| United States |
| SPARC Site 11 | Prescott | Arizona | 86301 | United States |
| SPARC Site 12 | Sun City | Arizona | 85351 | United States |
| SPARC site 01 | Fayetteville | Arkansas | 72704 | United States |
| SPARC Site 10 | Santa Barbara | California | 93110 | United States |
| SPARC Site 08 | Colorado Springs | Colorado | 80919 | United States |
| SPARC Site 06 | Coral Springs | Florida | 33067 | United States |
| SPARC Site 18 | Fort Myers | Florida | 33901 | United States |
| SPARC Site 16 | Jacksonville | Florida | 32204 | United States |
| SPARC Site 07 | Miami | Florida | 33143 | United States |
| SPARC Site 15 | Paducah | Kentucky | 42001 | United States |
| SPARC Site 05 | Saint Joseph | Michigan | 49085 | United States |
| SPARC Site 09 | Henderson | Nevada | 89052 | United States |
| SPARC Site 03 | Poughkeepsie | New York | 12603 | United States |
| SPARC Site 04 | Winston-Salem | North Carolina | 27101 | United States |
| SPARC Site 17 | Fargo | North Dakota | 58103 | United States |
| SPARC Site 19 | Austin | Texas | 78731 | United States |
| SPARC Site 2 | Mission | Texas | 78572 | United States |
| Modified Intent-to-Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
modified intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | SDN-037 | SDN-037: twice daily |
| BG001 | Vehicle | Placebo: twice daily |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | Grade Cell Count 0 0
ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of >0 at Day 15 visit was considered a failure (or non-responder) | Modified Intent-to-Treat Population | Posted | Count of Participants | Participants | Day 15 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects Who Achieve a Pain Score of 0 at Day 15 | Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent >100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity. | Modified Intent-To-Treat Population | Posted | Count of Participants | Participants | Day 15 |
|
|
Up to 6 visits over a period of 22 to 36 days
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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 | SDN-037 | SDN-037: twice daily | 0 | 154 | 2 | 154 | 87 | 154 |
| EG001 | Vehicle | Placebo: twice daily | 0 | 144 | 2 | 144 | 96 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous Retinal Detachment In Study Eye | Eye disorders | Systematic Assessment |
| ||
| Left Foot Infection Secondary To Trauma | Infections and infestations | Systematic Assessment |
| ||
| Cystoid Macula Edema | Eye disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell | Eye disorders | Systematic Assessment |
| ||
| Anterior chamber flare | Eye disorders | Systematic Assessment |
| ||
| Visual acuity reduced | Eye disorders | Systematic Assessment |
| ||
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Corneal oedema | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Photophobia | Eye disorders | Systematic Assessment |
| ||
| Intraocular pressure increased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head-Clinical Development | Sun Pharma Advanced Research Company Limited | 912266455645 | clinical.trials@sparcmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2020 | Mar 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|