ChalazionPhase 2NCT02338648
Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion
A Phase 2 study testing SUN-131 1.5% TDS in people with Chalazion, run by Senju USA, Inc. at 6 sites in United States.
Trial summary
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 chalazion based on the proportion of subjects that have complete response. Read more about this study
- Who is it for?
- Ages 18 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
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older of either sex and any race
- Chalazion with visible single granuloma in an upper or lower eyelid. If more than one eyelid is diagnosed with a chalazion, the most inflammatory chalazion shall be selected as the study eyelid. Other eyelids containing a chalazion will not be treated with investigational product in this trial.
- Chalazion intended for study treatment presents no more than 3 weeks based on subject history.
- Normal lid function
- Must be willing and able to correctly apply and wear a transdermal patch to the eyelid for 16±4 hours each day for repeated application
- Female subjects of childbearing potential must have a negative urine pregnancy test on Day 1, and must agree to use method of contraception from the start of study drug use and for 30 days after discontinuation of study drug. Approved methods of contraception include, an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner or oral contraceptives.
Show all 10Show fewer
- If male, subjects must be sterile or willing to use an approved method of contraception from the time of study drug administration to 30 days after discontinuation of study drug. Males must be willing to refrain from sperm donation within 30 days after study drug treatment.
- Are able and willing to attend all study visits and follow all study instructions.
- Have signed written informed consent before undergoing any study related procedures and is willing to comply with all study procedures.
- Avoid wearing contact lenses or any new facial cosmetic products during the study trial period.
Who cannot join
- Chalazion which have atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
- Chalazion at the lid margin.
- Active ocular or eyelid infection (bacterial, viral, or fungal), any ocular or eyelid condition that in the investigator's opinion could affect the subject's health or the study parameters.
- An abnormal skin condition on the upper and lower eyelid region of the eyelid (e.g. eczema, psoriasis, etc.) where the patches will be applied.
- Intraocular pressure greater than 22 mmHg.
- Diagnosed with glaucoma.
Show all 16Show fewer
- Use of oral and ocular therapy with a steroid within 7 days prior to administration of the study medication and during the study.
- Female subjects who are pregnant or lactating.
- Known allergy or sensitization to the test article or any formulation components.
- Major non-ocular surgery within 30 days prior to Day 1.
- History or evidence of ocular surgery within the past 3 months and/or a history of refractive surgery within the past 6 months.
- Planned surgery (ocular or systemic) during the trial period or within 30 days of removal of the transdermal patch.
- Participation in an investigational study within 30 days prior to Day 1.
- Have any ocular condition that requires chronic use of topical ophthalmic medication (e.g., glaucoma, dry eye, allergic conjunctivitis) with exception of artificial tear drops or lubricant eye drops or that, in the investigator's opinion, prevents the safe use of the patch.
- History of any previous functional or cosmetic eyelid surgery (including blepharopigmentation).
- Any other condition that, in the opinion of the investigator, renders the subject unsuitable for study participation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cornerstone Eye Care
High Point, North Carolina, 27262
Corneal Consultants of Colorado, P.C.
Littleton, Colorado, 80120
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Virginia Eye Consultants
Norfolk, Virginia, 23502
WCCT Global Ophthalmology Research
Santa Ana, California, 92705
George Washington University Medical Faculty Association
Washington D.C., District of Columbia, 20037
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 Adult Patients With a Chalazion
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 chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Read the detailed description
Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:
- SUN-131 1.5% TDS (n=30)
- Placebo TDS (n=30)
At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself.
All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present.
There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS.
Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study.
- 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
Active transdermal patch
Placebo TDSDrug
Placebo transdermal patch for blinding
| Study group | Role | What they receive |
|---|---|---|
| SUN-131 1.5% TDS | Experimental | Subjects will be randomly assigned to receive SUN-131 1.5% TDS for the affected eye. All patches will be worn for 16±4 hours each day for 21 days. Receives: Drug: SUN-131 1.5% TDS |
| Placebo TDS | Placebo comparator | Placebo Patch for Blinding Purposes Receives: Drug: Placebo TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Measured: Day 23±2
Secondary outcomes (6)
Change in Chalazion Size
Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
Measured: Study days 47 to 60
Change in Chalazion Erythema
Erythema of the chalazion site itself will be assessed using a 5-point scale (i.e. 0 = no signs of erythema; to 4 = severe erythema)
Measured: Study days 47 to 60
Pain Associated with the Chalazion
Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
Measured: Study days 47 to 60
Time to Complete Response of the Target Chalazion
Measured: Study days 47 to 60
Durability of Response
Clinical assessment of the presence of a chalazion if there was a complete response by Day 23±2.
Measured: Study days 47 to 60
Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms
Measured: Day 23±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT02338648
- Sponsor's protocol ID
- SUN-131-02
- Status last verified
- Jun 2017
- First submitted
- 31 Oct 2014
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
PubMed 16236742Draize JH. Dermal toxicity. Appraisal of Chemicals in Food, Drugs and Cosmetics: The Association of Food and Drug Officials of the United States (3rd printing 1975); 1959. p. 46-59
Ho SY, Lai JS. Subcutaneous steroid injection as treatment for chalazion: prospective case series. Hong Kong Med J. 2002 Feb;8(1):18-20.
PubMed 11861988Kaimbo Wa Kaimbo D, Nkidiaka MC. [Intralesional corticosteroid injection in the treatment of chalazion]. J Fr Ophtalmol. 2004 Feb;27(2):149-53. doi: 10.1016/s0181-5512(04)96109-8. French.
PubMed 15029042Ben Simon GJ, Huang L, Nakra T, Schwarcz RM, McCann JD, Goldberg RA. Intralesional triamcinolone acetonide injection for primary and recurrent chalazia: is it really effective? Ophthalmology. 2005 May;112(5):913-7. doi: 10.1016/j.ophtha.2004.11.037.
PubMed 15878075Ben Simon GJ, Rosen N, Rosner M, Spierer A. Intralesional triamcinolone acetonide injection versus incision and curettage for primary chalazia: a prospective, randomized study. Am J Ophthalmol. 2011 Apr;151(4):714-718.e1. doi: 10.1016/j.ajo.2010.10.026. Epub 2011 Jan 22.
PubMed 21257145Elsevier BH. Clinical Ocular Pharmacology. 5th Edition ed2008.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. 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 Adult Patients With a Chalazion
- ClinicalTrials.gov ID
- NCT02338648
- Acronym / sponsor ID
- SUN-131-02
- Conditions
- Chalazion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Senju USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Detailed description
Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:
- SUN-131 1.5% TDS (n=30)
- Placebo TDS (n=30)
At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself.
All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present.
There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS.
Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUN-131 1.5% TDS | Experimental | Drug: SUN-131 1.5% TDSSubjects will be randomly assigned to receive SUN-131 1.5% TDS for the affected eye. All patches will be worn for 16±4 hours each day for 21 days. |
| Placebo TDS | Placebo comparator | Drug: Placebo TDSPlacebo Patch for Blinding Purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older of either sex and any race
- Chalazion with visible single granuloma in an upper or lower eyelid. If more than one eyelid is diagnosed with a chalazion, the most inflammatory chalazion shall be selected as the study eyelid. Other eyelids containing a chalazion will not be treated with investigational product in this trial.
- Chalazion intended for study treatment presents no more than 3 weeks based on subject history.
- Normal lid function
- Must be willing and able to correctly apply and wear a transdermal patch to the eyelid for 16±4 hours each day for repeated application
Key exclusion criteria (16 listed)
- Chalazion which have atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
- Chalazion at the lid margin.
- Active ocular or eyelid infection (bacterial, viral, or fungal), any ocular or eyelid condition that in the investigator's opinion could affect the subject's health or the study parameters.
- An abnormal skin condition on the upper and lower eyelid region of the eyelid (e.g. eczema, psoriasis, etc.) where the patches will be applied.
- Intraocular pressure greater than 22 mmHg.
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% TDSActive transdermal patch | Drug | SUN-131 1.5% TDS |
| Placebo TDSPlacebo transdermal patch for blinding | Drug | Placebo TDS |
Primary outcome
Complete Response
Time frame: Day 23±2
Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
6 secondary outcomes
Change in Chalazion Size
Time frame: Study days 47 to 60
Change in Chalazion Erythema
Time frame: Study days 47 to 60
Pain Associated with the Chalazion
Time frame: Study days 47 to 60
Time to Complete Response of the Target Chalazion
Time frame: Study days 47 to 60
Durability of Response
Time frame: Study days 47 to 60
Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms
Time frame: Day 23±2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 16236742Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.
- BackgroundDraize JH. Dermal toxicity. Appraisal of Chemicals in Food, Drugs and Cosmetics: The Association of Food and Drug Officials of the United States (3rd printing 1975); 1959. p. 46-59
- Results publication: PubMed 11861988Ho SY, Lai JS. Subcutaneous steroid injection as treatment for chalazion: prospective case series. Hong Kong Med J. 2002 Feb;8(1):18-20.
- Results publication: PubMed 15029042Kaimbo Wa Kaimbo D, Nkidiaka MC. [Intralesional corticosteroid injection in the treatment of chalazion]. J Fr Ophtalmol. 2004 Feb;27(2):149-53. doi: 10.1016/s0181-5512(04)96109-8. French.
- Results publication: PubMed 15878075Ben Simon GJ, Huang L, Nakra T, Schwarcz RM, McCann JD, Goldberg RA. Intralesional triamcinolone acetonide injection for primary and recurrent chalazia: is it really effective? Ophthalmology. 2005 May;112(5):913-7. doi: 10.1016/j.ophtha.2004.11.037.
- Results publication: PubMed 21257145Ben Simon GJ, Rosen N, Rosner M, Spierer A. Intralesional triamcinolone acetonide injection versus incision and curettage for primary chalazia: a prospective, randomized study. Am J Ophthalmol. 2011 Apr;151(4):714-718.e1. doi: 10.1016/j.ajo.2010.10.026. Epub 2011 Jan 22.
- Results publicationElsevier BH. Clinical Ocular Pharmacology. 5th Edition ed2008.
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUN-131 1.5% TDS in people with Chalazion, run by Senju USA, Inc. at 6 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 10 inclusion and 16 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete Response (time frame: Day 23±2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338648, which also lists 7 linked publications.
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 11 Aug 2017.