A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye.

Purpose: To compare the efficacy and ocular tolerability of a 0.08% nanoemulsion cyclosporine A (CsA) (TJO-087) once daily versus a conventional 0.05% emulsion CsA twice daily in dry eye disease. Methods: 178 patients with dry eye disease were randomly assigned to one of two groups: the TJO-087 or CsA0.05% group. Changes in the Ocular Surface Disease Index (OSDI), tear film break-up time (TBUT), corneal and conjunctival staining scores, and Schirmer test scores from baseline to the 32-week visit were compared between both groups. To evaluate ocular tolerability of the study formulations, 7 symptoms (stinging/burning, itching, blurred vision, sandiness/grittiness, dryness, light sensitivity, and pain or soreness) were evaluated (the higher the score, the lower the tolerability) at each follow-up visit. Results: A total of 155 eyes of 155 patients were enrolled. The TJO-087 and CsA0.05% groups showed significant improvement in OSDI, TBUT, ocular surface staining, and Schirmer test scores at 32 weeks from baseline. There was no difference in the extent of improvement in all efficacy parameters. There were no differences in the ocular tolerability scores between the 2 groups at all visits, except that the itching score was higher in the TJO-087 group than in the CsA0.05% group at week 8. Conclusion: Using topical 0.08% CsA once daily is an effective therapeutic option for improving the symptoms and signs in dry eye disease, with a tolerability comparable with that of conventional 0.05% CsA. This trial was registered at the US National Library of Medicine ClinicalTrials.gov (http://clinicaltrial.gov) as NCT05245604 (registration date: 19/06/2020).