Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion
Primary Purpose
Chalazion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SUN-131 1.5% TDS
Placebo TDS
Sponsored by
About this trial
This is an interventional treatment trial for Chalazion
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- WCCT Global Ophthalmology Research
- Corneal Consultants of Colorado, P.C.
- George Washington University Medical Faculty Association
- Icahn School of Medicine at Mount Sinai
- Cornerstone Eye Care
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SUN-131 1.5% TDS
Placebo TDS
Arm Description
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.
Placebo Patch for Blinding Purposes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Chalazion Size
Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
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)
Pain Associated with the Chalazion
Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
Time to Complete Response of the Target Chalazion
Durability of Response
Clinical assessment of the presence of a chalazion if there was a complete response by Day 23±2.
Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02338648
Brief Title
Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senju USA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SUN-131 1.5% TDS
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo TDS
Arm Type
Placebo Comparator
Arm Description
Placebo Patch for Blinding Purposes
Intervention Type
Drug
Intervention Name(s)
SUN-131 1.5% TDS
Intervention Description
Active transdermal patch
Intervention Type
Drug
Intervention Name(s)
Placebo TDS
Intervention Description
Placebo transdermal patch for blinding
Primary Outcome Measure Information:
Title
Complete Response
Description
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.
Time Frame
Day 23±2
Secondary Outcome Measure Information:
Title
Change in Chalazion Size
Description
Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
Time Frame
Study days 47 to 60
Title
Change in Chalazion Erythema
Description
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)
Time Frame
Study days 47 to 60
Title
Pain Associated with the Chalazion
Description
Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
Time Frame
Study days 47 to 60
Title
Time to Complete Response of the Target Chalazion
Time Frame
Study days 47 to 60
Title
Durability of Response
Description
Clinical assessment of the presence of a chalazion if there was a complete response by Day 23±2.
Time Frame
Study days 47 to 60
Title
Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms
Time Frame
Day 23±2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
WCCT Global Ophthalmology Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Corneal Consultants of Colorado, P.C.
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
George Washington University Medical Faculty Association
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16236742
Citation
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.
Results Reference
background
Citation
Draize 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 Reference
background
PubMed Identifier
11861988
Citation
Ho SY, Lai JS. Subcutaneous steroid injection as treatment for chalazion: prospective case series. Hong Kong Med J. 2002 Feb;8(1):18-20.
Results Reference
result
PubMed Identifier
15029042
Citation
Kaimbo 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 Reference
result
PubMed Identifier
15878075
Citation
Ben 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 Reference
result
PubMed Identifier
21257145
Citation
Ben 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 Reference
result
Citation
Elsevier BH. Clinical Ocular Pharmacology. 5th Edition ed2008.
Results Reference
result
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Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion
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