Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (SUNRISE)
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ClinicalTrials.gov Identifier: NCT03248440 |
Recruitment Status :
Completed
First Posted : August 14, 2017
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chalazion | Drug: SUN-131 1.5% TDS Drug: Placebo TDS | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 263 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (SUN-131-03) |
Actual Study Start Date : | July 31, 2017 |
Actual Primary Completion Date : | August 17, 2018 |
Actual Study Completion Date : | August 17, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: SUN-131 1.5% TDS |
Drug: SUN-131 1.5% TDS
SUN-131 1.5% TDS will be worn for 14 days |
Placebo Comparator: Placebo TDS |
Drug: Placebo TDS
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 [ Time Frame: 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.
- The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 [ Time Frame: 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.

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects aged ≥ 6 years of either sex and of any race
- Subjects with a diagnosis of a single chalazion
- Subjects with chalazion erythema score of ≥ 1
- Normal eyelid function without active signs of eye and eyelid infection in either eye.
- Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
- Avoid wearing contact lenses in the study eye
Exclusion Criteria:
- Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
- History of chalazion incision and curettage in study eyelid.
- Multiple chalazia in any one eyelid.
- Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
- An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
- Diagnosed with glaucoma in either eye.
- History of steroid-induced elevation of IOP.
- Female subjects who are pregnant or lactating.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248440

Documents provided by Senju USA, Inc.:
Responsible Party: | Senju USA, Inc. |
ClinicalTrials.gov Identifier: | NCT03248440 |
Other Study ID Numbers: |
SUN-131-03 |
First Posted: | August 14, 2017 Key Record Dates |
Results First Posted: | August 5, 2021 |
Last Update Posted: | August 5, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Chalazion Cysts Neoplasms Eyelid Diseases Eye Diseases |