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

• Sponsor: Senju USA, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03248440
• Collaborator: (none)
• Enrollment: 263
• Locations: 65
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site: 4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jul 31, 2017
• Actual Primary Completion Date: Aug 17, 2018
• Actual Study Completion Date: Aug 17, 2018

Arms and Interventions

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

Primary Outcome Measures

1. 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 Outcome Measures

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]

   Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUN-131-03 Investigational Site	Chandler	Arizona	United States	85225
2	SUN-131-03 Investigational Site	Prescott	Arizona	United States	86301
3	SUN-131-03 Investigational Site	Sun City	Arizona	United States	85351
4	SUN-131-03 Investigational Site	Glendale	California	United States	91204
5	SUN-131-03 Investigational Site	Lancaster	California	United States	93534
6	SUN-131-03 Investigational Site	Long Beach	California	United States	90805
7	SUN-131-03 Investigational Site	Los Angeles	California	United States	90048
8	SUN-131-03 Investigational Site	Mission Hills	California	United States	91345
9	SUN-131-03 Investigational Site	Petaluma	California	United States	94954
10	SUN-131-03 Investigational Site	Rancho Cordova	California	United States	95670
11	SUN-131-03 Investigational Site	San Diego	California	United States	92115
12	SUN-131-03 Investigational Site	Santa Ana	California	United States	92705
13	SUN-131-03 Investigational Site	Colorado Springs	Colorado	United States	80907
14	SUN-131-03 Investigational Site	Littleton	Colorado	United States	80120
15	SUN-131-03 Investigational Site	Fort Myers	Florida	United States	33901
16	SUN-131-03 Investigational Site	Largo	Florida	United States	33773
17	SUN-131-03 Investigational Site	Maitland	Florida	United States	32751
18	SUN-131-03 Investigational Site	Tamarac	Florida	United States	33321
19	SUN-131-03 Investigational Site	Albany	Georgia	United States	31701
20	SUN-131-03 Investigational Site	Morrow	Georgia	United States	30260
21	SUN-131-03 Investigational Site	Roswell	Georgia	United States	30076
22	SUN-131-03 Investigational Site	Chicago Ridge	Illinois	United States	60415
23	SUN-131-03 Investigational Site	Glenview	Illinois	United States	60026
24	SUN-131-03 Investigational Site	Hoffman Estates	Illinois	United States	60169
25	SUN-131-03 Investigational Site	Lake Villa	Illinois	United States	60046
26	SUN-131-03 Investigational Site	Leawood	Kansas	United States	66211
27	SUN-131-03 Investigational Site	Shawnee Mission	Kansas	United States	66204
28	SUN-131-03 Investigational Site	Lexington	Kentucky	United States	40509
29	SUN-131-03 Investigational Site	Louisville	Kentucky	United States	40206
30	SUN-131-03 Investigational Site	Saint Joseph	Michigan	United States	49085
31	SUN-131-03 Investigational Site	Bloomington	Minnesota	United States	55420
32	SUN-131-03 Investigational Site	Kansas City	Missouri	United States	64133
33	SUN-131-03 Investigational Site	Saint Louis	Missouri	United States	63131
34	SUN-131-03 Investigational Site	Washington	Missouri	United States	63090
35	SUN-131-03 Investigational Site	Las Vegas	Nevada	United States	89119
36	SUN-131-03 Investigational Site	Las Vegas	Nevada	United States	89123
37	SUN-131-03 Investigational Site	Wantagh	New York	United States	11793
38	SUN-131-03 Investigational Site	Asheville	North Carolina	United States	28803
39	SUN-131-03 Investigational Site	Charlotte	North Carolina	United States	28210
40	SUN-131-03 Investigational Site	High Point	North Carolina	United States	27262
41	SUN-131-03 Investigational Site	Cincinnati	Ohio	United States	45236
42	SUN-131-03 Investigational Site	Cincinnati	Ohio	United States	45247
43	SUN-131-03 Investigational Site	Mason	Ohio	United States	45040
44	SUN-131-03 Investigational Site	Lancaster	Pennsylvania	United States	17601
45	SUN-131-03 Investigational Site	Lancaster	Pennsylvania	United States	19087
46	SUN-131-03 Investigational Site	Philadelphia	Pennsylvania	United States	19148
47	SUN-131-03 Investigational Site	Wayne	Pennsylvania	United States	19087
48	SUN-131-03 Investigational Site	Florence	South Carolina	United States	29501
49	SUN-131-03 Investigational Site	Rapid City	South Dakota	United States	57701
50	SUN-131-03 Investigational Site	Chattanooga	Tennessee	United States	37411
51	SUN-131-03 Investigational Site	Memphis	Tennessee	United States	38119
52	SUN-131-03 Investigational Site	Nashville	Tennessee	United States	37215
53	SUN-131-03 Investigational Site	Cedar Park	Texas	United States	78613
54	SUN-131-03 Investigational Site	Houston	Texas	United States	77008
55	SUN-131-03 Investigational Site	Houston	Texas	United States	77034
56	SUN-131-03 Investigational Site	Houston	Texas	United States	77055
57	SUN-131-03 Investigational Site	Lakeway	Texas	United States	78734
58	SUN-131-03 Investigational Site	Mission	Texas	United States	78572
59	SUN-131-03 Investigational Site	San Antonio	Texas	United States	78209
60	SUN-131-03 Investigational Site	San Antonio	Texas	United States	78240
61	SUN-131-03 Investigational Site	Salt Lake City	Utah	United States	84117
62	SUN-131-03 Investigational Site	Exmore	Virginia	United States	23350
63	SUN-131-03 Investigational Site	Falls Church	Virginia	United States	22046
64	SUN-131-03 Investigational Site	Norfolk	Virginia	United States	23456
65	SUN-131-03 Investigational Site	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

• Senju USA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2018

More Information

Publications

None provided.

• Responsible Party: Senju USA, Inc.
• ClinicalTrials.gov Identifier: NCT03248440
• Other Study ID Numbers: SUN-131-03
• First Posted: Aug 14, 2017
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chalazion

Study Results

Participant Flow

Arm/Group Title	Placebo TDS	SUN-131 1.5% TDS
Arm/Group Description	Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
Period Title: Overall Study
STARTED	131	132
COMPLETED	116	120
NOT COMPLETED	15	12

Baseline Characteristics

Arm/Group Title	Placebo TDS	SUN-131 1.5% TDS	Total
Arm/Group Description	Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	Total of all reporting groups
Overall Participants	131	132	263
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.8 (17.00)	49.0 (16.03)	47.9 (16.52)
Sex: Female, Male (Count of Participants)
Female	82 62.6%	81 61.4%	163 62%
Male	49 37.4%	51 38.6%	100 38%
Race/Ethnicity, Customized (Count of Participants)
White	88 67.2%	90 68.2%	178 67.7%
Black or African American	36 27.5%	31 23.5%	67 25.5%
Asian	3 2.3%	3 2.3%	6 2.3%
American Indian or Alaskan Native	1 0.8%	2 1.5%	3 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.8%	1 0.4%
Multi-racial (no primary race)	1 0.8%	3 2.3%	4 1.5%
Other	2 1.5%	2 1.5%	4 1.5%
Region of Enrollment (participants) [Number]
United States	131 100%	132 100%	263 100%

Outcome Measures

1. Primary Outcome

Title	The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants.

Arm/Group Title	Placebo TDS	SUN-131 1.5% TDS
Arm/Group Description	Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
Measure Participants	131	132
Count of Participants [Participants]	28 21.4%	32 24.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo TDS, SUN-131 1.5% TDS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.579
	Comments
	Method	2-sided Pearson's chi-square
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants with upper eyelid chalazion.

Arm/Group Title	Placebo TDS	SUN-131 1.5% TDS
Arm/Group Description	Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.	SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
Measure Participants	81	95
Count of Participants [Participants]	14 10.7%	27 20.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo TDS, SUN-131 1.5% TDS
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.082
	Comments
	Method	2-sided Pearson's chi-square
	Comments

Adverse Events

Time Frame	The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3).
Adverse Event Reporting Description	A Treatment-Emergent Adverse Event (TEAE) is an adverse event with a start date on or after the initial dose of study drug and up to 5 days after the last dose of study drug.
Arm/Group Title	Placebo TDS		SUN-131 1.5% TDS
Arm/Group Description	Placebo TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.		SUN-131 1.5% TDS was applied for a minimum of 16 hours and a maximum of 24 hours each day for 14 days.
All Cause Mortality
	Placebo TDS		SUN-131 1.5% TDS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		0/132 (0%)
Serious Adverse Events
	Placebo TDS		SUN-131 1.5% TDS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		0/132 (0%)
Other (Not Including Serious) Adverse Events
	Placebo TDS		SUN-131 1.5% TDS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/131 (14.5%)		23/132 (17.4%)
Cardiac disorders
Tachycardia	1/131 (0.8%)	1	0/132 (0%)	0
Ear and labyrinth disorders
Ear congestion	1/131 (0.8%)	1	0/132 (0%)	0
Eye disorders
Chalazion	4/131 (3.1%)	6	2/132 (1.5%)	2
Conjunctival follicles	1/131 (0.8%)	1	0/132 (0%)	0
Ocular hypertension	1/131 (0.8%)	1	0/132 (0%)	0
Pinguecula	1/131 (0.8%)	1	0/132 (0%)	0
Vision blurred	1/131 (0.8%)	1	2/132 (1.5%)	2
Blepharitis	0/131 (0%)	0	1/132 (0.8%)	1
Blepharospasm	0/131 (0%)	0	1/132 (0.8%)	1
Conjunctival hyperaemia	0/131 (0%)	0	1/132 (0.8%)	1
Dry eye	0/131 (0%)	0	1/132 (0.8%)	1
Eye irritation	0/131 (0%)	0	1/132 (0.8%)	1
Eyelid disorder	0/131 (0%)	0	1/132 (0.8%)	2
Eyelid pain	0/131 (0%)	0	1/132 (0.8%)	1
Lacrimation increased	0/131 (0%)	0	1/132 (0.8%)	1
Gastrointestinal disorders
Diarrhoea	1/131 (0.8%)	1	0/132 (0%)	0
Gastroesophageal reflux disease	0/131 (0%)	0	1/132 (0.8%)	1
Tooth loss	0/131 (0%)	0	1/132 (0.8%)	1
General disorders
Application site discomfort	1/131 (0.8%)	1	0/132 (0%)	0
Pain	1/131 (0.8%)	1	1/132 (0.8%)	1
Swelling	1/131 (0.8%)	1	0/132 (0%)	0
Application site erythema	0/131 (0%)	0	1/132 (0.8%)	1
Immune system disorders
Seasonal allergy	0/131 (0%)	0	1/132 (0.8%)	1
Infections and infestations
Upper respiratory tract infection	1/131 (0.8%)	1	1/132 (0.8%)	1
Nasopharyngitis	0/131 (0%)	0	2/132 (1.5%)	2
Bronchitis	0/131 (0%)	0	1/132 (0.8%)	1
Ear infection	0/131 (0%)	0	1/132 (0.8%)	1
Pharyngitis	0/131 (0%)	0	1/132 (0.8%)	1
Urinary tract infection	0/131 (0%)	0	1/132 (0.8%)	1
Nervous system disorders
Headache	1/131 (0.8%)	1	1/132 (0.8%)	1
Paraesthesia	1/131 (0.8%)	1	0/132 (0%)	0
Psychiatric disorders
Anxiety	0/131 (0%)	0	1/132 (0.8%)	1
Reproductive system and breast disorders
Adnexa uteri pain	0/131 (0%)	0	1/132 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Nasal dryness	0/131 (0%)	0	1/132 (0.8%)	1
Throat irritation	0/131 (0%)	0	1/132 (0.8%)	1
Skin and subcutaneous tissue disorders
Pruritus	5/131 (3.8%)	5	0/132 (0%)	0
Erythema	1/131 (0.8%)	1	0/132 (0%)	0
Acne	0/131 (0%)	0	2/132 (1.5%)	2
Skin irritation	0/131 (0%)	0	1/132 (0.8%)	1
Vascular disorders
Hypertension	0/131 (0%)	0	1/132 (0.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Principal Investigator will not disclose information regarding this clinical investigation, or publish results of the investigation without authorization from Senju USA, Inc.