Comparative Evaluation Of Two Formulations Of 0.05% Cyclosporine Eye Drops (Aqueous Solution Versus Oil Emulsion) In The Treatment Of Dry Eye Disease

To compare the clinical response of patients with moderate to severe dry eye disease to treatment with aqueous based and oil based 0.05% cyclosporine eye drops, as there are no clinical studies available in literature so far.

Randomized controlled clinical trial, 2 parallel arms, 3-month study done in Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, Delhi.

A total of 60 patients with moderate to severe dry eye disease, were enrolled after written informed consent and randomized to receive either aqueous based (Group 1) or oil based (Group 2) 0.05% cyclosporine eye drops in twice daily dosing (along with lubricants). Comprehensive eye examination and baseline parameters were recorded and clinical assessment repeated at 4, 8 and 12 weeks. Parameters evaluated included Ocular Surface Disease Index score (OSDI), Schirmer’s test, Corneal staining -National Eye Institute scoring (NEI), Meibography, LLT (Lipid Layer Thickness), Tear Meniscus Height (TMH) and Non Invasive Tear Break Up Time (NIBUT). 

The mean age was 39±3 years and 43±3 years and M:F ratio was 19:11 and 14:16 in group 1 and 2 respectively.Both the groups showed comparable values at baseline and statistically significant improvement from baseline for parameters-OSDI score(both Groups p<0.001),Schirmer’s(Group1–p–0.003,Group2-p<0.001),NEI score(Group1–p-0.003,Group2-p<0.001) and NIBUT(Group1-p<0.001 and Group2-p–0.001).TMH value showed statistically significant improvement only in Group2(p<0.001) compared to Group1(p - 0.121).Group2 showed a slightly better clinical response in OSDI score, TMH and NIBUT but showed a slightly increased meibomian gland loss compared to Group1 in all follow up visits.However, none of these differences were statistically significant(p>0.05).

Both aqueous based and oil based 0.05% cyclosporine formulations appears to be equally effective in the treatment of dry eye disease with a comparatively slightly better response with oil based formulation in terms of improvement in tear volume.