Cyclosporine 1mg/ml eye drop emulsion (Ikervis®) for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes: Clinical effectiveness, tolerability and safety in a real world setting.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Tolerability and safety in a real world setting

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Name of medicine:
  IKERVIS
• Medical condition to be studied:
  Dry eye

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The primary objective of this study is to assess the effectiveness of Ikervis® in controlling severe keratitis, as measured by corneal fluorescein staining (CFS) improvement from baseline to 12 months (± 45 days) from treatment initiation, in patients who have not improved despite treatment with tear substitutes, in routine clinical practice
• Outcomes:
  The primary endpoint is change in the grade of corneal fluorescein staining (CFS) from baseline to 12 months from initiation of Ikervis® treatment.baseline value will be collected and shall be measured only after obtaining informed consent and within 7 days before the start of Ikervis® treatment. Endpoint data will be collected 12 months (± 45 days) from the initiation of Ikervis® treatment. • To assess the following– foreign body sensation– burning/stinging– itching– pain– sticky feeling– blurred vision– photophobia• To assess tear production using Schirmer’s test• To assess tear film breakup time (TFBUT)• To evaluate eyelid and conjunctival erythema• Quantify reductions in the use of artificial tears• To quantify steroid tapering
• Data analysis plan:
  Statistical analysis:The unit of analysis will be patient’s worst eye which will be identified as the eye with the worst CFS score at baseline if both of a patient’s eyes are treated. If both eyes have the same CFS score then data from the right eye will be used. If only one eye is treated, then that eye will be the unit of study, irrespective of whether or not it was the worst eye at baseline.The primary endpoint analysis will be a comparison of the CFS score at baseline and at 12 months after Ikervis® treatment start. CFS score at baseline and at 12 months post Ikervis® initiation will be assessed as continuous variable as well as categorical variable based on oxford grading scale. CFS as categorical variable, as well as change in CFS after 12 months of treatment, will be summarized by their mode as these are ordinal variables, as well as by number and percentage of each.

Documents

Study, other information

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