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Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group

April 1, 2000

Clinical Trial

Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group.

Sall K, Stevenson OD, Mundorf TK, Reis BL.

Ophthalmology. 2000 Apr;107(4):631-9.
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Main finding: Cyclosporin A 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease, with improvement of both objective and subjective measures.

  • Purpose: To compare the efficacy and safety of cyclosporin A (0.05% and 0.1% ophthalmic emulsions) to vehicle in patients with moderate to severe dry eye disease.
  • Study type: Randomized controlled Trial
  • Condition: Dry Eye Disease

Participants:

 

Moderate to severe dry eye disease

 

  • n=877

 

Intervention:

Group 1: Cyclosporin A ophthalmic emulsion (0.05%)
Group 2: Cyclosporin A ophthalmic emulsion (0.1%)
Group 3: placebo

  • Cyclosporin A 0.05% and 0.1%, gave significantly greater improvements then vehicle in:
  • objective signs:
    • corneal staining and categorized Schirmer values
  • subjective measures:
    • blurred vision, need for concomitant artificial tears, and the physician’s evaluation of global

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