Improved Signs and Symptoms of Dry Eye Disease for Restasis

To evaluate dry eye disease (DED) signs and symptoms six months after a single treatment with Localized Heat Therapy (LHT) (TearCare, Sight Sciences) for patients previously treated for six months with cyclosporine (0.05%) ophthalmic emulsion (CsA) BID (Restasis, Allergan). Nineteen ophthalmic and optometric practices in 11 US states. Multicenter, cross-over, six month extension to the SAHARA randomized, controlled trial (RCT). Included patients were those randomized to CsA in Phase 1 of the SAHARA RCT. This was the second phase of the SAHARA RCT in which, following the 6-month endpoint, all patients that had been randomized to CsA discontinued CsA and were treated with LHT and subsequently followed for an additional six months. Outcome measures at 12 months for CsA patients crossed over to LHT included TBUT, OSDI and MGSS. One hundred and sixty-one patients (322 eyes) were analyzed. Mean (SD) baseline TBUT prior to CsA was 4.4 (1.2) seconds, 5.6 (2.6) at 6 months which improved to 6.6 (3.2) and 6.1 (2.8) seconds (both P < 0.001) at 9 and 12 months (3, 6 months post LHT). Mean (SD) OSDI was 50.0 (14.9) at baseline and 34.2 (21.5) after CsA. With LHT at 6 months, this improved to 30.0 (20.6) and 31.0 (19.5) at 9 and 12 months (P = 0.162 vs month 6, P < 0.0001 vs baseline). MGSS was 7.1 (3.2) at baseline, 13.3 (8.2) at the end of CsA treatment which improved to 17.4 (8.8) and 16.1 (9.0) at 9 and 12 months; both P <0.001. SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy.

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© 2024 Ayres et al.

Déclaration de conflit d'intérêts

BA, MB, JL, TC, BS, JE, and SK were Investigators and received research support for the study from the study sponsor, Sight Sciences, Inc. BA is a consultant for Alcon, Allergan, Sight Sciences, Carl Zeiss Meditech, Tarsus, and Dompe. MB is a consultant for and reports honoraria from Allergan and Sight Sciences. JL is a consultant for Allergan and Sight Sciences; she is also on advisory boards for Allergan, Bausch and Lomb and Sun Pharmaceuticals. TC reports grant support, consulting, and speaking for Sight Sciences and reports non-financial support from Allergan. 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. JED jr and TR are employees of Sight Sciences. The authors report no other conflicts of interest in this work.