NCT03248440|CompletedPhase 3ResultsFDA Drug

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

SUNRISE

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)

Senju USA, Inc.ClinicalTrials.gov

Compare

1 other identifier

SUN-131-03

Study Type

interventional

Target

263

Locations

1 country

Sites

Timeline

RegisteredAug 2017

StartedJul 2017

CompletionAug 2018

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

263

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2017

Shorter than P25 for phase_3

Geographic Reach

1 country

65 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

July 31, 2017

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed

3 years until next milestone

Results Posted

Study results publicly available

August 5, 2021

Completed

Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 9, 2017

Results QC Date

July 7, 2021

Last Update Submit

August 3, 2021

Conditions

Chalazion

Outcome Measures

Primary Outcomes (1)

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.
Baseline to Day 15 ± 1

Secondary Outcomes (1)

The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1
Baseline to Day 15 ± 1

Study Arms (2)

SUN-131 1.5% TDS

EXPERIMENTAL

Drug: SUN-131 1.5% TDS

Placebo TDS

PLACEBO COMPARATOR

Drug: Placebo TDS

Interventions

SUN-131 1.5% TDSDRUG

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

SUN-131 1.5% TDS

Placebo TDSDRUG

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

Placebo TDS

Eligibility Criteria

Age6 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.