VEKTIS Study Design

Washout Period (if applicable)

To be randomized patients must have:

  • VKC grade 3 or 4
    (Bonini scale)
  • Grade 4 or 5 corneal fluorescein staining (CFS; modified Oxford scale)
  • Mean VAS ≥60 mm (photophobia, tearing, itching, and mucous discharge)

Baseline (n=169)*

Randomization

Period I 4-month double-masked treatment
period: M 1, 2, 3 & 4 visits

  • (n=57)

    CsA CE 0.1% QID

  • (n=57)

    CsA CE 0.1% BID
    +
    Vehicle BID

  • (n=58)

    Vehicle QID

Period II 8-month double-masked safety
follow-up period: M 6, 8, 10 & 12 visits

May continue same regimen
as in Period I or may stop
May be randomized or may stop
  • (n=50)

    CsA CE 0.1% QID

  • (n=44)

    CsA CE 0.1% BID
    +
    Vehicle BID

  • (n=26)

    CsA CE 0.1% BID
    +
    Vehicle BID

  • (n=22)

    CsA CE 0.1% QID

*n=101 recruited in Europe
BID, twice daily; M, month; QID, four times daily; VAS, visual analogue scale
Leonardi A et al. Presented at 8th EU Cornea Congress; October 6–7, 2017; Lisbon, Portugal.

VEKTIS Key Study Endpoints

PRIMARY ENDPOINTS

  • Mean Composite Efficacy Score
    • Composite criterion based on:
      • Keratitis assessed by the modified Oxford scale (0 to 5)
      • Need for rescue medication (corticosteroid)
      • Occurrence of corneal ulceration
    • Patient score at month X = CFS (baseline) - CFS (Month X) + penalty(ies)
      • Penalty for rescue medication: -1 grade per course
      • Penalty for corneal ulceration: -1 grade per occurrence

SECONDARY ENDPOINTS

  • Four main VKC symptoms (photophobia, tearing, itching, and mucous discharge)
    • Assessed using a self-administered 100mm VAS, separately and globally (average of the 4 measures) at each visit
  • Quality of life
    • Assessed using the QUICK questionnaire; Subjects were asked about the preceding 2 weeks at baseline and each visit

VAS, visual analog scale
Leonardi A et al. Presented at 8th EU Cornea Congress; October 6–7, 2017; Lisbon, Portugal.

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