Purpose:This study aimed to evaluate the clinical manifestations and patient-reported outcomes related to Demodex blepharitis. Patients and Methods:In this observational, multicenter, cross-sectional, parallel-cohort study conducted at 7 sites in the United States, adult participants were assigned to study cohorts based on collarette grade: Control Cohort (no collarettes), Cohort 1 (1-10 collarettes), or Cohort 2 (>10 collarettes). Key outcome measures included collarette grading, lid margin erythema, ocular symptoms (itching, fluctuating vision, irritation, redness, and burning) measured on a visual analog scale (VAS), and the location of ocular itching when present. Results:A total of 147 participants were enrolled and completed the study: 47 in the Control Cohort, 46 in Cohort 1, and 54 in Cohort 2 (a total of 100 participants with ≥1 collarette, identified as having Demodex blepharitis). Eighty-five percent of patients with Demodex blepharitis were symptomatic, reporting at least 1 ocular symptom. Mean VAS scores were statistically significantly worse (higher) in participants with Demodex blepharitis for itching (24.5 vs 15.1, p = 0.025), fluctuating vision (24.2 vs 9.8, p = 0.0005), irritation (27.6 vs 17.3, p = 0.021), and redness (19.8 vs 9.9, p = 0.0128) compared to those without Demodex blepharitis. Mean VAS scores for burning were similar between cohorts. The lid margin was the most common location for ocular itching in patients with Demodex blepharitis compared to the corner(s) of the eye in patients without collarettes. Conclusion:This study demonstrated the vast majority (85%) of patients with Demodex blepharitis were symptomatic, reporting at least 1 ocular symptom, and an association between increasing collarette severity in participants with Demodex blepharitis and ocular symptoms (itching, fluctuating vision, irritation, and redness), as well as increased lid margin erythema.
IntroductionLotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis. MethodsPooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with <= 10 collarettes (grade 0 or 1 collarettes) at day 43. ResultsOverall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to <= 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable. ConclusionsTwice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.
Lotilaner ophthalmic solution (0.25
SIGNIFICANCE:Localized heat therapy with manual expression has been effective for meibomian gland dysfunction-associated dry eye disease in clinical studies including two randomized controlled trials, and in the present report, provides long-lasting relief from signs and symptoms for moderate-to-severe dry eye disease associated with meibomian gland dysfunction. PURPOSE:Meibomian gland dysfunction is a disease with high prevalence and accounts for most dry eye disease. Localized heat therapy with manual expression, an office-based intervention, has demonstrated effectiveness in improving the signs and symptoms of dry eye disease. The aim of this third phase of the Sahara randomized controlled trial was to study the durability of the treatment benefits. METHODS:Subjects randomized to localized heat therapy in Sahara and receiving second treatment at month 5 continued follow-up for an additional 19 months. Ocular signs including tear break-up time and meibomian gland secretion score, and symptoms including ocular surface disease index were assessed at months 6, 9, 12, 15, 18, and 24. Subjects could be retreated when tear break-up time was within 2 seconds of study baseline and ocular surface disease index increased by 15 points from the previous visit. RESULTS:One hundred sixty-six subjects entered this phase of the study. All measures of signs and symptoms (for the overall group of subjects) remained statistically significantly better than study baseline at all time points. Thirty-two subjects required additional treatment. Median time for retreatment was 8 months. Six-month retreatment-free survival probability was 92%. There were a few adverse events and none related to the localized heat therapy procedure. CONCLUSIONS:Localized heat therapy with manual expression has been shown to be an effective treatment for meibomian gland dysfunction, providing durable relief from dry eye disease signs and symptoms. Treatment twice per year can provide meaningful improvement and symptomatic relief for patients with moderate-to-severe dry eye disease.
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.
