The Evaluation of the Safety and Patient Satisfaction with Glash Vista in the Treatment of Patients with Hypotrichosis of the Eyelashes

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27604
• EU PAS number:
  EUPAS16107
• Study ID:
  27604
• Official title and acronym:
  The Evaluation of the Safety and Patient Satisfaction with Glash Vista in the Treatment of Patients with Hypotrichosis of the Eyelashes
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The purpose of this study is to evaluate the safety and patient satisfaction with Glash Vista in the treatment of bypotrichosis of the eyelash through active surveillance under routine clinical practice after the launch of the Glash Vista in Japan. Target Patient PopulationPatients who have been prescribed Glash Vista in select clinical settings and filled at least one prescription for Glash Vista. Sample Size1500 patients with hypotrichosis of the eyelashes who have been prescribed and have used Glash Vista at least once and also have completed at least one follow-up visitStudy Sites The study will be conducted in 75-300 medical institutions, mainly in the departments of dermatology, aesthetic plastic surgery and ophthalmology, recruiting 3-20 patients per institution. Doctors who agree to participate will fill out a registration form for their patients treated with the drug. After the follow-up period, participating doctors will fill out a case report form for each of their enrolled patients (including those who drop out from the study). Follow-upEnrolled patients will be follow-up for one after study enrollment. safety and patient satisfaction data will be collect at 1, 4 and 12 months after study enrollment. Study DurationPatients will be enrolled into the study during the first 2 and half years after study drug launch in Japan. Total study period is 3 and half years. Analysis The analyses will be descriptive in nature, and there are no plans for formal statistical hypothesis testing. Results will be displayed in tabular format (ie, summary statistics, frequency distribution of item responses, and incidence rates with corresponding 95% confidence intervals CI). No imputations for missing data are planned.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Quintiles

Study timelines

Date when funding contract was signed

Planned: 30/06/2014

Actual: 01/12/2014

Study start date

Actual: 24/12/2014

Date of final study report

Planned: 30/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

192024-089 PMS Protocol v2

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

192024-089