NCT02607683

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

November 16, 2015

Last Update Submit

November 6, 2017

Conditions

Steatoblepharon

Outcome Measures

Primary Outcomes (1)

  • LESS score (Clinician-Reported)

    16 weeks

Study Arms (3)

XAF5 (concentration A: 0.1%)

EXPERIMENTAL

Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily.

Drug: XAF5 (concentration A: 0.1%)

XAF5 (concentration B: 0.035%)

EXPERIMENTAL

Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily.

Drug: XAF5 (concentration B: 0.035%)

Placebo

PLACEBO COMPARATOR

Participants will apply Placebo Ointment to the lower eyelids once daily.

Drug: Matching placebo

Interventions

XAF5 (concentration A: 0.1%)DRUG
XAF5 (concentration A: 0.1%)
XAF5 (concentration B: 0.035%)DRUG
XAF5 (concentration B: 0.035%)
Matching placeboDRUG
Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

David Wirta, MD, Inc.

Newport Beach, California, United States

Location

OC Clinical Trials

Santa Ana, California, United States

Location

Danbury Eye Physicians

Danbury, Connecticut, United States

Location

Opthalmic Consultants of Boston

Boston, Massachusetts, United States

Location

South Shore Eye Care, Inc.

Wantagh, New York, United States

Location

Cincinatti Eye Institute

Cincinnati, Ohio, United States

Location

Study Officials

  • Julie Roth, Ph.D.

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

January 1, 2016

Primary Completion

September 19, 2016

Study Completion

October 31, 2016

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

US(6)