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

NCT02338648 | Completed Phase 2

• 1 other identifier: SUN-131-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

Chalazion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Chalazion Size

  Study days 47 to 60

• Change in Chalazion Erythema

  Study days 47 to 60

• Pain Associated with the Chalazion

  Study days 47 to 60

• Time to Complete Response of the Target Chalazion

  Study days 47 to 60

• Durability of Response

  Study days 47 to 60

Study Arms (2)

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.

Drug: SUN-131 1.5% TDS

Placebo TDS

PLACEBO COMPARATOR

Placebo Patch for Blinding Purposes

Drug: Placebo TDS

Interventions

SUN-131 1.5% TDS DRUG

Active transdermal patch

SUN-131 1.5% TDS

Placebo TDS DRUG

Placebo transdermal patch for blinding

Placebo TDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Senju USA, Inc.: lead

Study Sites (6)

WCCT Global Ophthalmology Research

Santa Ana, California, 92705, United States

Location

Corneal Consultants of Colorado, P.C.

Littleton, Colorado, 80120, United States

Location

George Washington University Medical Faculty Association

Washington D.C., District of Columbia, 20037, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cornerstone Eye Care

High Point, North Carolina, 27262, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Related Publications (7)

• 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.

  PMID: 16236742 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

  BACKGROUND

• Ho SY, Lai JS. Subcutaneous steroid injection as treatment for chalazion: prospective case series. Hong Kong Med J. 2002 Feb;8(1):18-20.

  PMID: 11861988 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.

  PMID: 15029042 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.

  PMID: 15878075 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.

  PMID: 21257145 RESULT

• Elsevier BH. Clinical Ocular Pharmacology. 5th Edition ed2008.

  RESULT

MeSH Terms

Conditions

Chalazion

Interventions

tyramine-deoxysorbitol

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: January 14, 2015
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-06

Locations

US (6)