NCT02505776

Brief Summary

This is a post-marketing surveillance study in Japan that will evaluate the safety and patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the treatment of hypotrichosis of the eyelashes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,699

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 8, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

July 21, 2015

Last Update Submit

August 13, 2018

Conditions

Eyelash Hypotrichosis

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Adverse Events

    Up to 12 Months

  • Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey

    Baseline, Month 1

  • Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey

    Baseline, Month 4

  • Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey

    Baseline, Month 12

Study Arms (1)

GLASH VISTA™

Patients with eyelash hypotrichosis prescribed bimatoprost cutaneous solution 0.03% (GLASH VISTA™) as per local standard of care in clinical practice.

Drug: Bimatoprost cutaneous solution 0.03%

Interventions

Bimatoprost cutaneous solution 0.03%DRUG

Bimatoprost cutaneous solution 0.03% (GLASH VISTA™) prescribed as per standard of care in clinical practice.

Also known as: GLASH VISTA™, Latisse®
GLASH VISTA™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with eyelash hypotrichosis

You may qualify if:

  • Patients who have been prescribed GLASH VISTA™ in clinical settings and filled at least one prescription for GLASH VISTA™.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Links

MeSH Terms

Interventions

Bimatoprost

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Suzanne St. Rose, Dr

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 22, 2015

Study Start

December 8, 2014

Primary Completion

May 21, 2018

Study Completion

May 21, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

JP(1)