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

Launched by SENJU USA, INC. · Aug 9, 2017

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Eligibility criteria

• 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.