TearCare outperforms cyclosporine in dry eye disease trial
TearCare (TC) demonstrates statistically superior and sustained improvements in tear break-up time (TBUT) and multiple measures of meibomian gland secretion compared to topical cyclosporine 0.05% (CsA) in the treatment of dry eye disease (DED), according to a study.
The study, a randomized, assessor-masked, controlled trial, involved 345 patients experiencing dry eye symptoms for 3-6 months. Participants had Tear Break-up Time (TBUT) ranging from ≥1 to ≤7 seconds, Meibomian Gland Secretion Score (MGSS) ≤12, and an Ocular Surface Disease Index (OSDI) between 23-79. Randomly assigned in a 1:1 ratio to either TC or CsA, TC patients received treatment at baseline and month 5, while CsA was administered twice daily for 6 months.
Follow-up visits were conducted on Day 1, Week 1, Months 1, 3, and 6, with primary assessments at Month 6. The results showed improvements in TBUT at all time points in both groups, with TC exhibiting a statistically greater improvement than CsA (P = 0.0006). OSDI improved significantly in both groups, with no notable difference between treatments. Notably, TC demonstrated superior improvements in MGSS and other measures of meibomian gland function compared to CsA.
Treatment-related adverse events were uncommon, with 10 reported in total, 8 of which were in the CsA group, aligning with prior studies on CsA. Most adverse events (9/10) were classified as mild.
Reference
Ayres BD, Bloomenstein MR, Loh J, et al. A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA). Clin Ophthalmol. 2023;17:3925-3940. doi: 10.2147/OPTH.S442971. PMID: 38143559; PMCID: PMC10741761.
