Clinical Ophthalmology (Dec 2023)

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

  • Ayres BD,
  • Bloomenstein MR,
  • Loh J,
  • Chester T,
  • Saenz B,
  • Echegoyen J,
  • Kannarr SR,
  • Perez VL,
  • Rodriguez TC,
  • Dickerson Jr JE

Journal volume & issue
Vol. Volume 17
pp. 3925 – 3940

Abstract

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Brandon D Ayres,1 Marc R Bloomenstein,2 Jennifer Loh,3 Thomas Chester,4 Bobby Saenz,5,6 Julio Echegoyen,7 Shane R Kannarr,8 Victor L Perez,9 Tomasita C Rodriguez,10 Jaime E Dickerson Jr10,11 1Private Practice, Philadelphia, PA, USA; 2Schwartz Laser Eye Center, Scottsdale, AZ, USA; 3Loh Ophthalmology Associates, Miami, FL, USA; 4Cleveland Eye Clinic, Brecksville, OH, USA; 5Rosenberg School of Optometry, University of the Incarnate Word, San Antonio, TX, USA; 6LASIK San Antonio, Kerrville, TX, USA; 7Gordon Schanzlin New Vision Institute, La Jolla, CA, USA; 8Kannarr Eye Care, Pittsburg, KS, USA; 9Department of Ophthalmology, Duke University Medical Center, Durham, NC, USA; 10Sight Sciences, Menlo Park, CA, USA; 11North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USACorrespondence: Jaime E Dickerson Jr, Email [email protected]: 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, conjunctival and corneal staining, eye dryness score (EDS), symptoms assessment in dry eye (SANDE) score, and Schirmer tear score (STS). Safety assessments included adverse events, best corrected visual acuity, intraocular pressure, and slit-lamp findings.Results: Overall, 345 subjects, 172 TC and 173 CsA. TBUT improved at all time points in both groups (p< 0.0001), with statistically greater improvement for TC versus CsA (p=0.0006). OSDI improved significantly at all time points in both groups (p< 0.0001) with no significant differences between treatments. MGSS and other measures of meibomian gland function improved significantly more with TC eyes versus CsA; other secondary outcomes showed significant improvements in both groups with no difference between groups. Treatment-related adverse events were uncommon (10 total, 8 in the CsA group consistent with prior CsA studies); most (9/10) mild.Conclusion: TC provides statistically superior and sustained improvement in TBUT and multiple measures of meibomian gland secretion, and non-inferior improvement in OSDI, corneal and conjunctival staining, SANDE, EDS, and STS versus CsA. TC should be a preferred treatment for DED associated with MGD.Keywords: dry eye disease, meibomian gland dysfunction, restasis, TearCare, cyclosporine

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