Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon
1 other identifier
interventional
90
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
February 8, 2016
CompletedFebruary 8, 2016
December 1, 2015
3 months
August 28, 2014
November 19, 2015
January 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.
11 weeks
Other Outcomes (2)
Patient Satisfaction Scale 1 (PSS1)
0-11 weeks
Patient Satisfaction Scale 2 (PSS2)
11 weeks
Study Arms (2)
XOPH5 Ointment
EXPERIMENTALXOPH5 Ointment is the investigational drug to be studied.
Placebo Ointment
PLACEBO COMPARATORPlacebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Topokine Therapeutics Clinical Study Centers
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Topokine Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Michael S. Singer, MD, PhD
Topokine Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
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
August 28, 2014
First Posted
September 3, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 8, 2016
Results First Posted
February 8, 2016
Record last verified: 2015-12