Evaluation of the Safety and Effectiveness of Lastacaft® Ophthalmic Solution 0.25%(Alcaftadine) for the Prevention of Itching Associated with Allergic Conjunctivitis: A Postmarketing Surveillance Study in Korea

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes, Active surveillance

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALCAFTADINE

Population studied

• Short description of the study population:
  Korean patients treated with Lastacaft for the prevention of itching associated with allergic conjunctivitis according to the approved label. This includes treatment of patients who were experiencing or anticipating symptoms of itching associated with allergic conjunctivitis, and for whom administration of Lastacaft has been decided.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The specific aims are to report on the: 1. Serious adverse events or adverse drug reactions 2. Unexpected adverse drug reactions that are not listed in the precautions for use in the product label 3. Known adverse drug reactions 4. Non-serious adverse events 5. Effectiveness as measured by a change from baseline in the patient's assessment of itching associated with allergic conjunctivitis
• Data analysis plan:
  Statistical analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the samples studied. Continuous variables (eg, age) will be summarized using the descriptive statistics including the number of non-missing observations, mean, standard deviation, median, minimum, and maximum values by visit. Categorical variables (eg, gender) will be summarized by the frequency counts and percentages in each category. Patients that use study treatment off-label will be analyzed separately. Patients that use Lastacaft for more than 3 months will be classified as “long-term users”. Long-term users will be analyzed separately.