A Randomized, Controlled Trial Comparing Tearcare^® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA).

ABSTRACT:

Purpose

We compare outcomes in eyes with dry eye disease (DED) treated with TearCare (TC) or topical cyclosporine 0.05% (RESTASIS; CsA).

Setting

Nineteen ophthalmic and optometric practices in 11 US states.

Design

Multicenter, randomized, assessor-masked, controlled IRB-approved trial. Eligible subjects: ≥22 years of age, dry eye symptoms within 3-6 months, Tear Break-up Time (TBUT) ≥1 to ≤7 s, Meibomian Gland Secretion Score (MGSS) ≤12, Ocular Surface Disease Index (OSDI) of 23-79. Randomized (1:1) to TC or CsA. TC subjects treated at baseline and month 5; CsA was twice daily for 6 months.

Methods

Follow-up visits were scheduled for Day 1, Week 1, Months 1, 3, and 6 with primary inference at Month 6. Primary outcomes: TBUT and OSDI; secondary outcomes: MGSS, c

SUBMITTER: Ayres BD 

PROVIDER: S-EPMC10741761 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature