Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)

Topokine Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)

Treatments: Drug: Placebo; Drug: XOPH5 Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02230761

XOPH5-OINT-2

Details and patient eligibility

About

This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).

Enrollment: 90 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (abbreviated):

• Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally)
• Men and women 40-70 years old
• Healthy facial skin
• Must understand and provide informed consent

Exclusion Criteria (abbreviated):

• Best corrected visual acuity worse than 20/40 in either eye
• Regular use of ophthalmic medication in either eye
• Planned use of contact lenses during the study
• Any history of lower eyelid surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

XOPH5 Ointment

Experimental group

Description:

XOPH5 Ointment is the investigational drug to be studied.

Treatment:

Drug: XOPH5 Ointment

Placebo Ointment

Placebo Comparator group

Description:

Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.

Treatment:

Drug: Placebo