Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chalazion

Intervention / Treatment
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* Drug: SUN-131 1.5% TDS
* Drug: Placebo TDS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUN-131 1.5% TDS<br>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. | Drug: SUN-131 1.5% TDS<br>* Active transdermal patch<br>|
| Placebo Comparator: Placebo TDS<br>Placebo Patch for Blinding Purposes | Drug: Placebo TDS<br>* Placebo transdermal patch for blinding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 23±2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Chalazion Size | Size of the chalazion will be assessed using a caliper and measured as height and width in mm. | 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) | 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. | Study days 47 to 60 | 
| Time to Complete Response of the Target Chalazion |  | 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. | Study days 47 to 60 | 
| Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms |  | Day 23±2 |