Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)

November 6, 2017 updated by: Topokine Therapeutics, Inc.

A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon

This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States
        • David Wirta, MD, Inc.
      • Santa Ana, California, United States
        • OC Clinical Trials
    • Connecticut
      • Danbury, Connecticut, United States
        • Danbury Eye Physicians
    • Massachusetts
      • Boston, Massachusetts, United States
        • Opthalmic Consultants of Boston
    • New York
      • Wantagh, New York, United States
        • South Shore Eye Care, Inc.
    • Ohio
      • Cincinnati, Ohio, United States
        • Cincinatti Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe, bilateral lower eyelid steatoblepharon
  • Must understand and provide informed consent
  • Healthy facial skin

Exclusion Criteria:

  • Pregnant or lactating women
  • Clinically significant eye disease
  • Best corrected visual acuity worse than 20/40 in either eye
  • History of eye surgery in past 6 months
  • History of lower eyelid surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XAF5 (concentration A: 0.1%)
Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily.
Drug: XAF5 (concentration A: 0.1%)
Experimental: XAF5 (concentration B: 0.035%)
Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily.
Drug: XAF5 (concentration B: 0.035%)
Placebo Comparator: Placebo
Participants will apply Placebo Ointment to the lower eyelids once daily.
Drug: Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LESS score (Clinician-Reported)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topokine Therapeutics, Inc.

Investigators

  • Study Director: Julie Roth, Ph.D., Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 19, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • XOPH5-OINT-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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