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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Glash Vista
• Medical condition to be studied:
  Hypotrichosis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  1) Safety of Glash Vista treatment in patient with hypotrichosis of the eyelashes by identifying and evaluating adverse events (AEs) and rates of these events, including serious adverse events (SAEs) and non-serious AEs2) Patient satisfaction with Glash Vista in the treatment of patients with hypotrichosis of the eyelashes by evaluating pre- and post- treatment patient satisfaction surveys
• Outcomes:
  Incidence of the following:a. Iridal hyperpigmentationb. Enophthalmos (deepened eyelid sulcus)c. Periorbital tissue hyperpigmentationd. Punctate Keratitis, a) Other AEsb) Patient satisfaction
• Data analysis plan:
  Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. Categorical variables (eg, gender) will be summarized by the number and percentage (%) of patients in each category. For describing the incidence of adverse events, the frequency, cumulative incidence proportion, patient-year incidence rate, and 95%CI for the cumulative incidence measures will be displayed. Unless otherwise specified, the 95% CI of the proportions will be calculated using the exact method, and the 95% CI of the incidence rates will be constructed assuming the frequency of a particular event in a given period of time follows a Poisson distribution.A frequency table by type of adverse event will be prepared. The causal relationship to Glash Vista, outcome and treatment for AE will be described.