Two randomized controlled trials compared the efficacy and safety of cyclosporine 0.05% and 0.10% ophthalmic emulsions to their vehicle in treating moderate to severe dry eye disease. Both concentrations of cyclosporine significantly improved corneal staining and blurred vision compared to vehicle after 4-6 months. Cyclosporine was well tolerated with few discontinuing due to adverse events. The studies found topical cyclosporine effective and safe for treating dry eye disease.

1. Two Multicenter, Randomized Studies of the Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry Eye Disease Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. Ophthalmology. 2000 Apr;107(4):631-9. Journal Club Terry J. Alexandrou, MD Department of Ophthalmology and Visual Science University of Chicago

6. Materials and Methods

18. Results

20. Patient Demographics No differences between treatment groups Sjogrens – Ocular and oral symptoms, Schirmer ≤5mm, and 1 of following: ANA, RF, SS-A, SS-B

21. Efficacy – Corneal Staining Statistically significant improvement in all treatment groups (P < 0.001) At 4 months, both CsA groups demonstrated statistically significant improvement compared to vehicle (P < .044) At 6 months, CsA 0.05% group demonstrated statistically significant improvement compared to vehicle (P < .044)

22. Efficacy – Schirmer Tear Test Statistically significant improvement in CsA 0.05% at month 3, and in both CsA groups at month 6

23. Efficacy – Symptoms of Dry Eye Decrease in blurred vision statistically significant in both CsA groups at all f/u visits, but only significant in vehicle group at month 6 visit. 5 Point Scale: 0 = do not have this symptom 4 = always have this symptom

24. Efficacy – Concomitant use of Artificial Tears

25. Safety Analyses

26. Safety Analyses

27. Superficial Conjunctiva Epithelium Biopsies

29. Study Weakness

31. Corneal Staining Oxford scheme 6 point scale – each investigator used same photos At baseline, mean value between 2.61 and 2.77 for ALL treatment groups Statistically significant improvement in all treatment groups (P < 0.001) At 4 months, both CsA groups demonstrated statistically significant improvement compared to vehicle (P < .044) At 6 months, CsA 0.05% group demonstrated statistically significant improvement compared to vehicle (P < .044)

32. Schirmer Values At baseline, mean values ranged between 1.94 and 2.11 At 6 months, statistically significant improvement from baseline and from vehicle in both CsA groups

33. Blurred Vision 5 Point Scale: 0 = do not have this symptom 4 = always have this symptom At baseline, mean value between 1.83 and 2.04 for ALL treatment groups Why not use actual visual acuities?

34. Use of Lubricating Drops