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Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (SUNRISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248440
Recruitment Status : Completed
First Posted : August 14, 2017
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Senju USA, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chalazion Drug: SUN-131 1.5% TDS Drug: Placebo TDS Phase 3

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Senju USA, Inc.
  Study Documents (Full-Text)

Documents provided by Senju USA, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] August 30, 2018

More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases