Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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)
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SUN-131 1.5% TDS 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
Active transdermal patch
|
| Placebo Comparator: Placebo TDS Placebo Patch for Blinding Purposes |
Drug: Placebo TDS
Placebo transdermal patch for blinding
|
Outcome Measures
Primary Outcome Measures
- Complete Response [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.
Secondary Outcome Measures
- Change in Chalazion Size [Study days 47 to 60]
Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
- Change in Chalazion Erythema [Study days 47 to 60]
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 [Study days 47 to 60]
Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
- Time to Complete Response of the Target Chalazion [Study days 47 to 60]
- Durability of Response [Study days 47 to 60]
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 [Day 23±2]
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older of either sex and any race
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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.
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Chalazion intended for study treatment presents no more than 3 weeks based on subject history.
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Normal lid function
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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
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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.
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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.
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Are able and willing to attend all study visits and follow all study instructions.
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Have signed written informed consent before undergoing any study related procedures and is willing to comply with all study procedures.
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Avoid wearing contact lenses or any new facial cosmetic products during the study trial period.
Exclusion Criteria:
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Chalazion which have atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
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Chalazion at the lid margin.
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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.
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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.
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Intraocular pressure greater than 22 mmHg.
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Diagnosed with glaucoma.
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Use of oral and ocular therapy with a steroid within 7 days prior to administration of the study medication and during the study.
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Female subjects who are pregnant or lactating.
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Known allergy or sensitization to the test article or any formulation components.
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Major non-ocular surgery within 30 days prior to Day 1.
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History or evidence of ocular surgery within the past 3 months and/or a history of refractive surgery within the past 6 months.
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Planned surgery (ocular or systemic) during the trial period or within 30 days of removal of the transdermal patch.
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Participation in an investigational study within 30 days prior to Day 1.
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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.
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History of any previous functional or cosmetic eyelid surgery (including blepharopigmentation).
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Any other condition that, in the opinion of the investigator, renders the subject unsuitable for study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | WCCT Global Ophthalmology Research | Santa Ana | California | United States | 92705 |
| 2 | Corneal Consultants of Colorado, P.C. | Littleton | Colorado | United States | 80120 |
| 3 | George Washington University Medical Faculty Association | Washington, D.C. | District of Columbia | United States | 20037 |
| 4 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 5 | Cornerstone Eye Care | High Point | North Carolina | United States | 27262 |
| 6 | Virginia Eye Consultants | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- Senju USA, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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
- Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. Review.
- SUN-131-02