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, 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

Data Sharing Statement

The authors do not intend to share participant-level data. Other queries or requests should be directed to the corresponding author (JD).

Acknowledgments

We are grateful to Dr. David Badawi for review and advice on this paper. Dr. Tony Realini (Hypotony LLC) provided medical writing services for a preliminary draft of the manuscript. Dr. Yuxin Zhang (Xtiers Consulting) provided statistical analysis.

Disclosure

BA, MB, JL, TC, BS, JE, and SK were Investigators and received research support for the study. BA is a consultant for Allergan and Sight Sciences. MB is a consultant for and reports honoraria from Allergan and Sight Sciences. JL is a consultant for Allergan and Sight Sciences and reports personal fees from Sun Ophthalmics, Alcon, and Bausch and Lomb, outside the submitted work. TC reports grant support, consulting, and speaking for Sight Sciences. BS is a consultant and speaker for Sight Sciences and Allergan. SK is a consultant and speaker for Allergan and a consultant for Sight Sciences. VP reports consulting fees from Sight Sciences, grants from Alcon; stock options from Claris; grants, personal fees from Novartis; personal fees from Dompe, Oyster Point, Oculis, Novaliq, Sun Pharma, Quidel, BrightStar and Kala; stock options from Trefoil; personal fees, stock options from Kuria, outside the submitted work. JD and TR are employees of Sight Sciences. There are no other relevant conflicts.