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This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5% TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of a chalazion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUN-131 1.5% TDS | Experimental |
| |
| Placebo TDS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUN-131 1.5% TDS | Drug | SUN-131 1.5% TDS will be worn for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 | Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator. | Baseline to Day 15 ± 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 | Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator. | Baseline to Day 15 ± 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUN-131-03 Investigational Site | Chandler | Arizona | 85225 | United States | ||
| SUN-131-03 Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo TDS | Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. |
| FG001 | SUN-131 1.5% TDS | SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2018 |
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| Placebo TDS |
| Drug |
No active substance; Placebo TDS will be worn each day for 14 days |
|
| Prescott |
| Arizona |
| 86301 |
| United States |
| SUN-131-03 Investigational Site | Sun City | Arizona | 85351 | United States |
| SUN-131-03 Investigational Site | Glendale | California | 91204 | United States |
| SUN-131-03 Investigational Site | Lancaster | California | 93534 | United States |
| SUN-131-03 Investigational Site | Long Beach | California | 90805 | United States |
| SUN-131-03 Investigational Site | Los Angeles | California | 90048 | United States |
| SUN-131-03 Investigational Site | Mission Hills | California | 91345 | United States |
| SUN-131-03 Investigational Site | Petaluma | California | 94954 | United States |
| SUN-131-03 Investigational Site | Rancho Cordova | California | 95670 | United States |
| SUN-131-03 Investigational Site | San Diego | California | 92115 | United States |
| SUN-131-03 Investigational Site | Santa Ana | California | 92705 | United States |
| SUN-131-03 Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| SUN-131-03 Investigational Site | Littleton | Colorado | 80120 | United States |
| SUN-131-03 Investigational Site | Fort Myers | Florida | 33901 | United States |
| SUN-131-03 Investigational Site | Largo | Florida | 33773 | United States |
| SUN-131-03 Investigational Site | Maitland | Florida | 32751 | United States |
| SUN-131-03 Investigational Site | Tamarac | Florida | 33321 | United States |
| SUN-131-03 Investigational Site | Albany | Georgia | 31701 | United States |
| SUN-131-03 Investigational Site | Morrow | Georgia | 30260 | United States |
| SUN-131-03 Investigational Site | Roswell | Georgia | 30076 | United States |
| SUN-131-03 Investigational Site | Chicago Ridge | Illinois | 60415 | United States |
| SUN-131-03 Investigational Site | Glenview | Illinois | 60026 | United States |
| SUN-131-03 Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| SUN-131-03 Investigational Site | Lake Villa | Illinois | 60046 | United States |
| SUN-131-03 Investigational Site | Leawood | Kansas | 66211 | United States |
| SUN-131-03 Investigational Site | Shawnee Mission | Kansas | 66204 | United States |
| SUN-131-03 Investigational Site | Lexington | Kentucky | 40509 | United States |
| SUN-131-03 Investigational Site | Louisville | Kentucky | 40206 | United States |
| SUN-131-03 Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| SUN-131-03 Investigational Site | Bloomington | Minnesota | 55420 | United States |
| SUN-131-03 Investigational Site | Kansas City | Missouri | 64133 | United States |
| SUN-131-03 Investigational Site | St Louis | Missouri | 63131 | United States |
| SUN-131-03 Investigational Site | Washington | Missouri | 63090 | United States |
| SUN-131-03 Investigational Site | Las Vegas | Nevada | 89119 | United States |
| SUN-131-03 Investigational Site | Las Vegas | Nevada | 89123 | United States |
| SUN-131-03 Investigational Site | Wantagh | New York | 11793 | United States |
| SUN-131-03 Investigational Site | Asheville | North Carolina | 28803 | United States |
| SUN-131-03 Investigational Site | Charlotte | North Carolina | 28210 | United States |
| SUN-131-03 Investigational Site | High Point | North Carolina | 27262 | United States |
| SUN-131-03 Investigational Site | Cincinnati | Ohio | 45236 | United States |
| SUN-131-03 Investigational Site | Cincinnati | Ohio | 45247 | United States |
| SUN-131-03 Investigational Site | Mason | Ohio | 45040 | United States |
| SUN-131-03 Investigational Site | Lancaster | Pennsylvania | 17601 | United States |
| SUN-131-03 Investigational Site | Lancaster | Pennsylvania | 19087 | United States |
| SUN-131-03 Investigational Site | Philadelphia | Pennsylvania | 19148 | United States |
| SUN-131-03 Investigational Site | Wayne | Pennsylvania | 19087 | United States |
| SUN-131-03 Investigational Site | Florence | South Carolina | 29501 | United States |
| SUN-131-03 Investigational Site | Rapid City | South Dakota | 57701 | United States |
| SUN-131-03 Investigational Site | Chattanooga | Tennessee | 37411 | United States |
| SUN-131-03 Investigational Site | Memphis | Tennessee | 38119 | United States |
| SUN-131-03 Investigational Site | Nashville | Tennessee | 37215 | United States |
| SUN-131-03 Investigational Site | Cedar Park | Texas | 78613 | United States |
| SUN-131-03 Investigational Site | Houston | Texas | 77008 | United States |
| SUN-131-03 Investigational Site | Houston | Texas | 77034 | United States |
| SUN-131-03 Investigational Site | Houston | Texas | 77055 | United States |
| SUN-131-03 Investigational Site | Lakeway | Texas | 78734 | United States |
| SUN-131-03 Investigational Site | Mission | Texas | 78572 | United States |
| SUN-131-03 Investigational Site | San Antonio | Texas | 78209 | United States |
| SUN-131-03 Investigational Site | San Antonio | Texas | 78240 | United States |
| SUN-131-03 Investigational Site | Salt Lake City | Utah | 84117 | United States |
| SUN-131-03 Investigational Site | Exmore | Virginia | 23350 | United States |
| SUN-131-03 Investigational Site | Falls Church | Virginia | 22046 | United States |
| SUN-131-03 Investigational Site | Norfolk | Virginia | 23456 | United States |
| SUN-131-03 Investigational Site | Racine | Wisconsin | 53405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all randomized subjects who received the study drug. Intent-to-treat (ITT) population included all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo TDS | Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. |
| BG001 | SUN-131 1.5% TDS | SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 | Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator. | Intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | Baseline to Day 15 ± 1 |
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| Secondary | The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 | Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator. | Intent-to-treat (ITT) population included all randomized participants with upper eyelid chalazion. | Posted | Count of Participants | Participants | Baseline to Day 15 ± 1 |
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The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3).
A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
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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 | Placebo TDS | Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. | 0 | 131 | 0 | 131 | 19 | 131 |
| EG001 | SUN-131 1.5% TDS | SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. | 0 | 132 | 0 | 132 | 23 | 132 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Conjunctival follicles | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Pinguecula | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Blepharospasm | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Eyelid disorder | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Eyelid pain | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Application site discomfort | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Tooth loss | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
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The Principal Investigator will not disclose information regarding this clinical investigation, or publish results of the investigation without authorization from Senju USA, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Takahiro Ogawa, PhD | Senju USA, Inc. | +1 818 719 7190 | ogawataka@senju-usa.com |
| Oct 13, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017043 | Chalazion |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C076628 | tyramine-deoxysorbitol |
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| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaskan Native |
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| Native Hawaiian or Other Pacific Islander |
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| Multi-racial (no primary race) |
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| Other |
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