Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion

• SUN-131 1.5% TDS (Drug): SUN-131 1.5% TDS will be worn for 14 days
• Placebo TDS (Drug): No active substance; Placebo TDS will be worn each day for 14 days

Primary outcomes

• The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 [Baseline to Day 15 ± 1]: Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Secondary outcomes

• The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 [Baseline to Day 15 ± 1]: Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.

Sex: All, ages: 6 Years to any

Inclusion Criteria:

1. Subjects aged ≥ 6 years of either sex and of any race
2. Subjects with a diagnosis of a single chalazion
3. Subjects with chalazion erythema score of ≥ 1
4. Normal eyelid function without active signs of eye and eyelid infection in either eye.
5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
6. Avoid wearing contact lenses in the study eye

Exclusion Criteria:

1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
2. History of chalazion incision and curettage in study eyelid.
3. Multiple chalazia in any one eyelid.
4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
6. Diagnosed with glaucoma in either eye.
7. History of steroid-induced elevation of IOP.
8. Female subjects who are pregnant or lactating.

Participant flow

Outcome results

• The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1 (Primary), Count of participants, Participants: Placebo TDS 28; SUN-131 1.5% TDS 32 (p 0.579)
• The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1 (Secondary), Count of participants, Participants: Placebo TDS 14; SUN-131 1.5% TDS 27 (p 0.082)

Adverse events

Time frame: The reporting period for AEs started after the first study drug application on Day 1 and ended at Follow-up Telephone Contact (Day 22 ± 3).

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-08-30)