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Safety and Patient Satisfaction With GLASH VISTA™ (Bimatoprost 0.03%) in the Treatment of Eyelash Hypotrichosis in Japan

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ClinicalTrials.gov Identifier: NCT02505776
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment
Eyelash Hypotrichosis Drug: Bimatoprost cutaneous solution 0.03%

Study Type : Observational
Actual Enrollment : 1704 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : December 8, 2014
Estimated Primary Completion Date : June 8, 2018
Estimated Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost

Group/Cohort Intervention/treatment
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%
Bimatoprost cutaneous solution 0.03% (GLASH VISTA™) prescribed as per standard of care in clinical practice.
Other Names:
  • GLASH VISTA™
  • Latisse®




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to 12 Months ]
  2. Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey [ Time Frame: Baseline, Month 1 ]
  3. Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey [ Time Frame: Baseline, Month 4 ]
  4. Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey [ Time Frame: Baseline, Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with eyelash hypotrichosis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505776


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Vice President Medical Affairs Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02505776     History of Changes
Other Study ID Numbers: 192024-089
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Pharmaceutical Solutions
Bimatoprost
Antihypertensive Agents