A Phase 3 interventional study of SUN-131 1.5% TDS and Placebo TDS in Chalazion, sponsored by Senju USA, Inc.. Completed at 65 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by Senju USA, Inc. · Phase 3, Interventional, and Treatment
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.
Senju USA, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SUN-131 1.5% TDS
Drug: Placebo TDS
SUN-131 1.5% TDS will be worn for 14 days
No active substance; Placebo TDS will be worn each day for 14 days
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.
Time frame: Baseline to Day 15 ± 1
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.
Time frame: Baseline to Day 15 ± 1
| Milestone | Placebo TDS | SUN-131 1.5% TDS |
|---|---|---|
| Started | 131 | 132 |
| Completed | 116 | 120 |
| Not completed | 15 | 12 |
Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
| Participants | Placebo TDS | SUN-131 1.5% TDS |
|---|---|---|
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 | 28 | 32 |
Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
| Participants | Placebo TDS | SUN-131 1.5% TDS |
|---|---|---|
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 | 14 | 27 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo TDS | 0/131 (0%) | 0/131 (0%) | 19/131 (14.5%) |
| SUN-131 1.5% TDS | 0/132 (0%) | 0/132 (0%) | 23/132 (17.4%) |
| Event | Placebo TDS | SUN-131 1.5% TDS |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 5/131 | 0/132 |
| ChalazionEye disorders | 4/131 | 2/132 |
| Vision blurredEye disorders | 1/131 | 2/132 |
| AcneSkin and subcutaneous tissue disorders | 0/131 | 2/132 |
| NasopharyngitisInfections and infestations | 0/131 | 2/132 |
| Conjunctival folliclesEye disorders | 1/131 | 0/132 |
| Ocular hypertensionEye disorders | 1/131 | 0/132 |
| PingueculaEye disorders | 1/131 | 0/132 |
| Application site discomfortGeneral disorders | 1/131 | 0/132 |
| PainGeneral disorders | 1/131 | 1/132 |
Safety population included all randomized subjects who received the study drug. Intent-to-treat (ITT) population included all randomized subjects.
| Age, Continuous(years) | Placebo TDS | SUN-131 1.5% TDS | Total |
|---|---|---|---|
| Mean | 46.8 ± 17.00 | 49.0 ± 16.03 | 47.9 ± 16.52 |
| Sex: Female, Male(Participants) | Placebo TDS | SUN-131 1.5% TDS | Total |
|---|---|---|---|
| Female | 82 | 81 | 163 |
| Male | 49 | 51 | 100 |
| Race/Ethnicity, Customized(Participants) | Placebo TDS | SUN-131 1.5% TDS | Total |
|---|---|---|---|
| White | 88 | 90 | 178 |
| Black or African American | 36 | 31 | 67 |
| Asian | 3 | 3 | 6 |
| American Indian or Alaskan Native | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Multi-racial (no primary race) | 1 | 3 | 4 |
| Other | 2 | 2 | 4 |
| Region of Enrollment(participants) | Placebo TDS | SUN-131 1.5% TDS | Total |
|---|---|---|---|
| United States | 131 | 132 | 263 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Chalazion
Senju USA, Inc.