<p>TearCare^&reg; system extension study: evaluation of the safety, effectiveness, and durability through 12 months of a second TearCare^&reg; treatment on subjects with dry eye disease</p>

Abstract

PurposeEvaluation of the safety and effectiveness of a TearCare® retreatment in adult subjects with clinically significant dry eye disease (DED).Patients and methodsThis was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study. In the initial study, subjects with DED were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point. The TearCare® retreatment procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual meibomian gland clearance. The primary effectiveness end point was the change in tear break-up time (TBUT) from baseline to 1-month follow-up. Secondary end points included meibomian gland scores, corneal and conjunctival staining scores, and assessment of dry eye symptoms. Safety was evaluated through monitoring intraocular pressure, best-corrected visual acuity, and device-related adverse events.ResultsTwelve subjects participated in the 6-month extension study. At 1-month clinic visit following retreatment, a significant improvement from baseline in mean (± SD) TBUT of 12.4 (±3.3) seconds was observed (P<0.001). Significant improvements in the mean change from baseline in meibomian gland scores, corneal and conjunctival staining scores, and symptoms of DED were also observed following retreatment. The second treatment was well tolerated.ConclusionThe findings of the extension study through 12 months suggest that a second TearCare® treatment after 6 months provides additional improvement in the signs and symptoms of DED.

Therapeutic Instruments Targeting Meibomian Gland Dysfunction

“…The system encourages meibum expression through normal blinking during the treatment and through the subsequent manual MG expression—the set includes a disposable EXPRESS™ Forceps to perform the manoeuvre. Badawi et al [ 22 , 23 ] performed a clinical trial (I) evaluating the effectiveness of the TearCare ® System and the MGDRx EyeBag ® in two different groups of MGD patients. While one group underwent the TearCare ® for 12 min and subsequent MG expression, the other group self-applied 5 min of daily therapy with EyeBag ® for 4 weeks.…”

A Single-center Retrospective Trial of a Blink-assisted Eyelid Device in Treating the Signs and Symptoms of Dry Eye

“… 19 A 6-month extension of this study in which a subset of patients received a second treatment 7 months after the first saw significant improvements in symptoms. 26 Interestingly, the mean Symptom Assessment iN Dry Eye scores were reduced even further than they had been after the first treatment. 26 …”

“… 26 Interestingly, the mean Symptom Assessment iN Dry Eye scores were reduced even further than they had been after the first treatment. 26 …”

“… 19 In the 6-month extension study, the author reported a statistically significant improvement from baseline at 1 year in meibomian gland scores, corneal and conjunctival staining scores, and symptoms of dry eye disease after a second treatment at 6 months. 26 In a previous exploratory study (Cheetah), improvements in both dry eye disease signs (tear breakup time, meibomian gland secretion score, corneal and conjunctival staining) and symptoms (Ocular Surface Disease Index) were observed at both 1-week and 1-month time points for TearCare in comparison to placebo. 27 Hovanesian et al 28 reported the effectiveness of TearCare comparable with LipiFlow for 135 patients with dry eye disease in terms of improvement in tear breakup time, meibomian gland scores, and Ocular Surface Disease Index scores in their prospective, single-masked, controlled, randomized, multicenter pivotal study (OLYMPIA).…”

A Prospective, Post-Market, Multicenter Trial (CHEETAH) Suggested TearCare® System as a Safe and Effective Blink-Assisted Eyelid Device for the Treatment of Dry Eye Disease

“…11 The TearCare System (Sight Sciences, Inc, Menlo Park, CA, USA) represents an innovation that overcomes these limitations to enable long-lasting safe and effective treatment of both signs and symptoms of DED. 12,13 The TearCare procedure couples a custom-designed medical device which delivers a safe, precisely controlled, and maximum therapeutic level of heat to the meibomian glands to thoroughly melt all hardened meibum obstructions and manual gland expression in a medical office to fully evacuate all meibomian glands and restore the natural flow of meibum, thus effectively interrupting the vicious cycle of evaporative DED. The objective of the study presented herein was to further evaluate the safety and effectiveness of a single TearCare procedure to treat adult patients with DED.…”