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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.
Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo TDS | Placebo Comparator | Placebo Patch for Blinding Purposes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUN-131 1.5% TDS | Drug | Active transdermal patch |
| |
| Placebo TDS |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global Ophthalmology Research | Santa Ana | California | 92705 | United States | ||
| Corneal Consultants of Colorado, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16236742 | Background | 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. | |
| Background | 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 | ||
| 11861988 |
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| ID | Term |
|---|---|
| D017043 | Chalazion |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C076628 | tyramine-deoxysorbitol |
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| Drug |
Placebo transdermal patch for blinding |
|
| 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 |
| Littleton |
| Colorado |
| 80120 |
| United States |
| George Washington University Medical Faculty Association | Washington D.C. | District of Columbia | 20037 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| Result |
| Ho SY, Lai JS. Subcutaneous steroid injection as treatment for chalazion: prospective case series. Hong Kong Med J. 2002 Feb;8(1):18-20. |
| 15029042 | Result | 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. |
| 15878075 | Result | 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. |
| 21257145 | Result | 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. |
| Result | Elsevier BH. Clinical Ocular Pharmacology. 5th Edition ed2008. |