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

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العنوان: A Randomized, Controlled Trial Comparing Tearcare ® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA).
المؤلفون: Ayres BD; Private Practice, Philadelphia, PA, USA., Bloomenstein MR; Schwartz Laser Eye Center, Scottsdale, AZ, USA., Loh J; Loh Ophthalmology Associates, Miami, FL, USA., Chester T; Cleveland Eye Clinic, Brecksville, OH, USA., Saenz B; Rosenberg School of Optometry, University of the Incarnate Word, San Antonio, TX, USA.; LASIK San Antonio, Kerrville, TX, USA., Echegoyen J; Gordon Schanzlin New Vision Institute, La Jolla, CA, USA., Kannarr SR; Kannarr Eye Care, Pittsburg, KS, USA., Perez VL; Department of Ophthalmology, Duke University Medical Center, Durham, NC, USA., Rodriguez TC; Sight Sciences, Menlo Park, CA, USA., Dickerson JE Jr; Sight Sciences, Menlo Park, CA, USA.; North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USA.
المصدر: Clinical ophthalmology (Auckland, N.Z.) [Clin Ophthalmol] 2023 Dec 18; Vol. 17, pp. 3925-3940. Date of Electronic Publication: 2023 Dec 18 (Print Publication: 2023).
نوع المنشور: Case Reports; Clinical Trial
اللغة: English
بيانات الدورية: Publisher: Dove Medical Press Country of Publication: New Zealand NLM ID: 101321512 Publication Model: eCollection Cited Medium: Print ISSN: 1177-5467 (Print) Linking ISSN: 11775467 NLM ISO Abbreviation: Clin Ophthalmol Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Auckland : Dove Medical Press, c2007-
مستخلص: 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.
Competing Interests: 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.
(© 2023 Ayres et al.)
فهرسة مساهمة: Keywords: TearCare; cyclosporine; dry eye disease; meibomian gland dysfunction; restasis
تواريخ الأحداث: Date Created: 20231225 Latest Revision: 20231225
رمز التحديث: 20231225
مُعرف محوري في PubMed: PMC10741761
DOI: 10.2147/OPTH.S442971
PMID: 38143559
قاعدة البيانات: MEDLINE
الوصف
تدمد:1177-5467
DOI:10.2147/OPTH.S442971