ChalazionPhase 3SUNRISENCT03248440
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
A Phase 3 study testing SUN-131 1.5% TDS in people with Chalazion, run by Senju USA, Inc. at 65 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Chalazion
- What is being tested?
- SUN-131 1.5% TDS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 65 sitesUnited States
- Study dates
- 31 Jul 2017to 17 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
SUN-131-03 Investigational Site
Albany, Georgia, 31701
SUN-131-03 Investigational Site
Asheville, North Carolina, 28803
SUN-131-03 Investigational Site
Bloomington, Minnesota, 55420
SUN-131-03 Investigational Site
Cedar Park, Texas, 78613
SUN-131-03 Investigational Site
Chandler, Arizona, 85225
SUN-131-03 Investigational Site
Charlotte, North Carolina, 28210
SUN-131-03 Investigational Site
Chattanooga, Tennessee, 37411
SUN-131-03 Investigational Site
Chicago Ridge, Illinois, 60415
SUN-131-03 Investigational Site
Cincinnati, Ohio, 45236
SUN-131-03 Investigational Site
Cincinnati, Ohio, 45247
SUN-131-03 Investigational Site
Colorado Springs, Colorado, 80907
SUN-131-03 Investigational Site
Exmore, Virginia, 23350
SUN-131-03 Investigational Site
Falls Church, Virginia, 22046
SUN-131-03 Investigational Site
Florence, South Carolina, 29501
SUN-131-03 Investigational Site
Fort Myers, Florida, 33901
SUN-131-03 Investigational Site
Glendale, California, 91204
SUN-131-03 Investigational Site
Glenview, Illinois, 60026
SUN-131-03 Investigational Site
High Point, North Carolina, 27262
SUN-131-03 Investigational Site
Hoffman Estates, Illinois, 60169
SUN-131-03 Investigational Site
Houston, Texas, 77008
SUN-131-03 Investigational Site
Houston, Texas, 77034
SUN-131-03 Investigational Site
Houston, Texas, 77055
SUN-131-03 Investigational Site
Kansas City, Missouri, 64133
SUN-131-03 Investigational Site
Lake Villa, Illinois, 60046
SUN-131-03 Investigational Site
Lakeway, Texas, 78734
SUN-131-03 Investigational Site
Lancaster, California, 93534
SUN-131-03 Investigational Site
Lancaster, Pennsylvania, 17601
SUN-131-03 Investigational Site
Lancaster, Pennsylvania, 19087
SUN-131-03 Investigational Site
Largo, Florida, 33773
SUN-131-03 Investigational Site
Las Vegas, Nevada, 89119
SUN-131-03 Investigational Site
Las Vegas, Nevada, 89123
SUN-131-03 Investigational Site
Leawood, Kansas, 66211
SUN-131-03 Investigational Site
Lexington, Kentucky, 40509
SUN-131-03 Investigational Site
Littleton, Colorado, 80120
SUN-131-03 Investigational Site
Long Beach, California, 90805
SUN-131-03 Investigational Site
Los Angeles, California, 90048
SUN-131-03 Investigational Site
Louisville, Kentucky, 40206
SUN-131-03 Investigational Site
Maitland, Florida, 32751
SUN-131-03 Investigational Site
Mason, Ohio, 45040
SUN-131-03 Investigational Site
Memphis, Tennessee, 38119
SUN-131-03 Investigational Site
Mission, Texas, 78572
SUN-131-03 Investigational Site
Mission Hills, California, 91345
SUN-131-03 Investigational Site
Morrow, Georgia, 30260
SUN-131-03 Investigational Site
Nashville, Tennessee, 37215
SUN-131-03 Investigational Site
Norfolk, Virginia, 23456
SUN-131-03 Investigational Site
Petaluma, California, 94954
SUN-131-03 Investigational Site
Philadelphia, Pennsylvania, 19148
SUN-131-03 Investigational Site
Prescott, Arizona, 86301
SUN-131-03 Investigational Site
Racine, Wisconsin, 53405
SUN-131-03 Investigational Site
Rancho Cordova, California, 95670
SUN-131-03 Investigational Site
Rapid City, South Dakota, 57701
SUN-131-03 Investigational Site
Roswell, Georgia, 30076
SUN-131-03 Investigational Site
Saint Joseph, Michigan, 49085
SUN-131-03 Investigational Site
Salt Lake City, Utah, 84117
SUN-131-03 Investigational Site
San Antonio, Texas, 78209
SUN-131-03 Investigational Site
San Antonio, Texas, 78240
SUN-131-03 Investigational Site
San Diego, California, 92115
SUN-131-03 Investigational Site
Santa Ana, California, 92705
SUN-131-03 Investigational Site
Shawnee Mission, Kansas, 66204
SUN-131-03 Investigational Site
St Louis, Missouri, 63131
SUN-131-03 Investigational Site
Sun City, Arizona, 85351
SUN-131-03 Investigational Site
Tamarac, Florida, 33321
SUN-131-03 Investigational Site
Wantagh, New York, 11793
SUN-131-03 Investigational Site
Washington, Missouri, 63090
SUN-131-03 Investigational Site
Wayne, Pennsylvania, 19087
About this study
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)
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.
- Conditions
- Chalazion
- Being tested
- SUN-131 1.5% TDS, Placebo TDS
- Medical subject headings
- Chalazion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUN-131 1.5% TDSDrug
SUN-131 1.5% TDS will be worn for 14 days
Placebo TDSDrug
No active substance; Placebo TDS will be worn each day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| SUN-131 1.5% TDS | Experimental | Not described Receives: Drug: SUN-131 1.5% TDS |
| Placebo TDS | Placebo comparator | Not described Receives: Drug: Placebo TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
Measured: Baseline to Day 15 ± 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start31 Jul 2017
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ChalazionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senju USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248440
- Sponsor's protocol ID
- SUN-131-03
- Acronym
- SUNRISE
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2017
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03248440
- Acronym / sponsor ID
- SUNRISE / SUN-131-03
- Conditions
- Chalazion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Senju USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUN-131 1.5% TDS | Experimental | Drug: SUN-131 1.5% TDS |
| Placebo TDS | Placebo comparator | Drug: Placebo TDS |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUN-131 1.5% TDSSUN-131 1.5% TDS will be worn for 14 days | Drug | SUN-131 1.5% TDS |
| Placebo TDSNo active substance; Placebo TDS will be worn each day for 14 days | Drug | Placebo TDS |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chalazion
Not yet recruitingPhase 2
Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
Pediatric Chalazia
Recruiting
Is the Use of a Steam Mask an Effective Treatment for Paediatric Chalazion in Comparison to Traditional Warm Compresses?
Chalazion
Not yet recruiting
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
Chalazion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SUN-131 1.5% TDS in people with Chalazion, run by Senju USA, Inc. at 65 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 (time frame: Baseline to Day 15 ± 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.