TearCare for the Treatment of Meibomian Gland Dysfunction in Adult Patients With Dry Eye Disease: A Masked Randomized Controlled Trial.

PURPOSE: The aim of this study was to demonstrate the safety and effectiveness of a single TearCare procedure compared with a single LipiFlow procedure in treatment of the dry eye disease associated with meibomian gland dysfunction. METHODS: In a multicenter, masked, randomized controlled trial, 135 subjects received a single TearCare (TC) treatment (n = 67) or a single LipiFlow (LF) treatment (n = 68) at baseline and were followed up for 1 month posttreatment. Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores were assessed as dry eye signs at baseline, 2 weeks, and 1 month; dry eye symptoms were assessed using the Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires at baseline and 1 month. RESULTS: At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5 in the TC group and 34.9 ± 26.9, 38.0 ± 25.9, and 23.4 ± 17.7 in the LF group, respectively. There were no statistically significant differences for any result between the groups. However, the TC group demonstrated numerically greater improvements consistently in all signs and symptoms. Device-related ocular adverse events were reported in 3 patients in the TC group (superficial punctate keratitis, chalazion, and blepharitis) and 4 patients in the LF group (blepharitis, 2 cases of foreign body sensation, and severe eye dryness). CONCLUSIONS: A single TearCare treatment significantly alleviates the signs and symptoms of dry eye disease in patients with meibomian gland dysfunction and is equivalent in its safety and effectiveness profile to LipiFlow treatment as shown in this 1-month follow-up study.

Effect of the Bruder moist heat eye compress on contact lens discomfort in contact lens wearers: An open-label randomized clinical trial.

The purpose of this study was to investigate the effect of the Bruder Moist Heat Compress on contact lens (CL) discomfort in subjects with contact lens-related dry eye (CLDE). This was a 4-week, single-center, three-arm, randomized, open-label clinical trial in subjects diagnosed with CLDE using the Contact Lens Dry Eye Questionnaire. Fifty-one CL wearers were randomized to one of three treatment groups: application of the Bruder Compress twice a day, Bruder Compress once a day, or warm washcloth used for ten minutes twice a day without reheating. Subject diaries were monitored for compliance and collected data on daily CL comfort upon awakening and throughout the afternoon. Clinical assessments included tear film break-up time (TBUT), lipid layer thickness (LLT), and meibomian gland evaluation. Statistical tests included a generalized linear model and one-way analysis of variance (ANOVA) to investigate treatment effect on comfortable wear time. Fifty-one subjects (98% female) completed the study. After treatment, subjects using a washcloth reported more uncomfortable contact lens wear time on average (mean = 5.1 ± 2.8 h) when compared with subjects who had used the Bruder Compress in Group 1 (mean = 2.8 ± 1.6 h) (p = 0.02). In the Bruder Compress groups, there was a significant reduction in the blockage of meibomian glands (p < 0.01). No significant difference in uncomfortable wear time was found between subjects using the Bruder Compress twice daily versus once daily (p = 0.48). Subjects using the Bruder Compress once daily had the highest rate of compliance at 90.2% (p < 0.01). No significant improvements were observed in TBUT (p = 0.76) or LLT (p = 0.78). The Bruder Moist Heat Compress resulted in a significant improvement in comfortable CL wear time in subjects with CLDE.