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Completed

NCT Number: NCT03248440

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

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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Key information

Conditions

Chalazion Cysts Eye Diseases Eyelid Diseases Neoplasms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SUN-131-03 Investigational Site, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SUN-131 1.5% TDS

Drug

SUN-131 1.5% TDS will be worn for 14 days

Placebo TDS

Drug

No active substance; Placebo TDS will be worn each day for 14 days

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Senju USA, Inc.

Industry

Registry information

Official study 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)

Acronym: SUNRISE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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