PMID- 38143559
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231225
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 17
DP  - 2023
TI  - A Randomized, Controlled Trial Comparing Tearcare((R)) and Cyclosporine Ophthalmic 
      Emulsion for the Treatment of Dry Eye Disease (SAHARA).
PG  - 3925-3940
LID - 10.2147/OPTH.S442971 [doi]
AB  - 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.
CI  - (c) 2023 Ayres et al.
FAU - Ayres, Brandon D
AU  - Ayres BD
AD  - Private Practice, Philadelphia, PA, USA.
FAU - Bloomenstein, Marc R
AU  - Bloomenstein MR
AD  - Schwartz Laser Eye Center, Scottsdale, AZ, USA.
FAU - Loh, Jennifer
AU  - Loh J
AD  - Loh Ophthalmology Associates, Miami, FL, USA.
FAU - Chester, Thomas
AU  - Chester T
AUID- ORCID: 0000-0002-9078-6670
AD  - Cleveland Eye Clinic, Brecksville, OH, USA.
FAU - Saenz, Bobby
AU  - Saenz B
AUID- ORCID: 0000-0001-6961-1836
AD  - Rosenberg School of Optometry, University of the Incarnate Word, San Antonio, TX, 
      USA.
AD  - LASIK San Antonio, Kerrville, TX, USA.
FAU - Echegoyen, Julio
AU  - Echegoyen J
AD  - Gordon Schanzlin New Vision Institute, La Jolla, CA, USA.
FAU - Kannarr, Shane R
AU  - Kannarr SR
AD  - Kannarr Eye Care, Pittsburg, KS, USA.
FAU - Perez, Victor L
AU  - Perez VL
AD  - Department of Ophthalmology, Duke University Medical Center, Durham, NC, USA.
FAU - Rodriguez, Tomasita C
AU  - Rodriguez TC
AD  - Sight Sciences, Menlo Park, CA, USA.
FAU - Dickerson, Jaime E Jr
AU  - Dickerson JE Jr
AUID- ORCID: 0000-0001-6748-9742
AD  - Sight Sciences, Menlo Park, CA, USA.
AD  - North Texas Eye Research Institute, University of North Texas Health Science 
      Center, Fort Worth, TX, USA.
LA  - eng
PT  - Case Reports
PT  - Clinical Trial
DEP - 20231218
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC10741761
OTO - NOTNLM
OT  - TearCare
OT  - cyclosporine
OT  - dry eye disease
OT  - meibomian gland dysfunction
OT  - restasis
COIS- 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.
EDAT- 2023/12/25 06:42
MHDA- 2023/12/25 06:43
PMCR- 2023/12/18
CRDT- 2023/12/25 04:17
PHST- 2023/10/25 00:00 [received]
PHST- 2023/12/11 00:00 [accepted]
PHST- 2023/12/25 06:43 [medline]
PHST- 2023/12/25 06:42 [pubmed]
PHST- 2023/12/25 04:17 [entrez]
PHST- 2023/12/18 00:00 [pmc-release]
AID - 442971 [pii]
AID - 10.2147/OPTH.S442971 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2023 Dec 18;17:3925-3940. doi: 10.2147/OPTH.S442971. eCollection 
      2023.