Improved Signs and Symptoms of Dry Eye Disease for Restasis® Patients Following a Single Tearcare® Treatment: Phase 2 of the SAHARA Study.

Purpose: 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). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: 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. Methods: 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. Results: 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. Conclusion: 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.

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

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.

Call to action: treating dry eye disease and setting the foundation for successful surgery.

Dry eye disease (DED) is a common disease that can reduce the quality of life. Prevalence estimates vary but have been reported to be as high as 60% in some populations. Diagnosis is complicated by a multifactorial etiology and a disconnection between clinical signs and patient-reported symptomatology. Critically, preexisting DED can exacerbate postoperative dry eye symptoms and reduce patient satisfaction after ocular surgery, highlighting the value of thorough evaluation and screening for signs and symptoms of DED in preparation for ocular surgery. This article reviewed predisposing and exacerbating factors for DED and presented an argument for the importance of adequately treating DED prior to surgery, from the perspective of both the patient and the provider. It briefly reviewed currently available methodologies and emphasized the utility of multimodal diagnosis and treatment algorithms to optimize outcomes and patient satisfaction.

Evaluation of Same-Day versus Next-Day Implantation of Intracanalicular Dexamethasone for the Control of Postoperative Inflammation and Pain Following Cataract Surgery.

PURPOSE: To evaluate the safety and efficacy of a sustained-release intracanalicular dexamethasone insert for postoperative inflammation and pain implanted in a clinical setting preoperatively or on postoperative day 1. METHODS: Single-site, retrospective, contralateral eye study of patients undergoing cataract surgery. Included were subjects with a dexamethasone intracanalicular insert implanted in the clinic immediately prior to surgery in one eye (same-day) and on postoperative day 1 (POD1) in the contralateral eye. The primary outcome measure was the resolution of anterior chamber inflammation at 1 week postoperative. Secondary outcome measures included proportion of eyes requiring additional therapy for pain and inflammation through 1 month as well as the number of eyes with IOP spikes above baseline. Safety measures included adverse events through 1 month postoperative. RESULTS: Sixty-two eyes of 31 subjects were included in the case series. At 1 week postoperative, 52% of the eyes (n = 16) achieved complete resolution of inflammation in the same-day group and 58% (n = 18) met this endpoint at 1 week in the POD1 group. One subject in the same-day group required additional therapy for rebound inflammation and no eyes required additional therapy in the POD1 group. There were no reports of pain at 1 week or 1 month in either group. There were no implant-related adverse events in either group. CONCLUSION: The favorable results of this study indicate that the sustained-release dexamethasone insert can be safely implanted in the clinic either preoperatively on the day of surgery or on postoperative day 1 for the control of pain and inflammation following cataract surgery.