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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Lower Eyelid Steatoblepharon (Excess Eyelid Fat)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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XOPH5 Ointment

XOPH5 Ointment is the investigational drug to be studied.

Group Type EXPERIMENTAL

XOPH5 Ointment

Intervention Type DRUG

Placebo Ointment

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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XOPH5 Ointment

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No