Chalazion
Conditions
Brief summary
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.
Interventions
DRUGSUN-131 1.5% TDS
SUN-131 1.5% TDS will be worn for 14 days
DRUGPlacebo TDS
No active substance; Placebo TDS will be worn each day for 14 days
Sponsors
Senju USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects aged ≥ 6 years of either sex and of any race 2. Subjects with a diagnosis of a single chalazion 3. Subjects with chalazion erythema score of ≥ 1 4. Normal eyelid function without active signs of eye and eyelid infection in either eye. 5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid 6. Avoid wearing contact lenses in the study eye
Exclusion criteria
1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues). 2. History of chalazion incision and curettage in study eyelid. 3. Multiple chalazia in any one eyelid. 4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid. 5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied. 6. Diagnosed with glaucoma in either eye. 7. History of steroid-induced elevation of IOP. 8. Female subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 | Baseline to 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo TDS Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days. | 131 |
| 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. | 132 |
| Total | 263 |
Baseline characteristics
| Characteristic | Placebo TDS | SUN-131 1.5% TDS | Total |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 17 | 49.0 years STANDARD_DEVIATION 16.03 | 47.9 years STANDARD_DEVIATION 16.52 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 36 Participants | 31 Participants | 67 Participants |
| Race/Ethnicity, Customized Multi-racial (no primary race) | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 88 Participants | 90 Participants | 178 Participants |
| Region of Enrollment United States | 131 participants | 132 participants | 263 participants |
| Sex: Female, Male Female | 82 Participants | 81 Participants | 163 Participants |
| Sex: Female, Male Male | 49 Participants | 51 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 132 |
| other Total, other adverse events | 19 / 131 | 23 / 132 |
| serious Total, serious adverse events | 0 / 131 | 0 / 132 |
Outcome results
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.
Time frame: Baseline to Day 15 ± 1
Population: Intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo TDS | The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 | 28 Participants |
| SUN-131 1.5% TDS | The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 | 32 Participants |
p-value: 0.5792-sided Pearson's chi-square
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.
Time frame: Baseline to Day 15 ± 1
Population: Intent-to-treat (ITT) population included all randomized participants with upper eyelid chalazion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo TDS | The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 | 14 Participants |
| SUN-131 1.5% TDS | The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 | 27 Participants |
p-value: 0.0822-sided Pearson's chi-square