Original article
Evaluation of an eyelid warming device (Blephasteam®) for the management of ocular surface diseases in France: The ESPOIR studyÉvaluation de Blephasteam®, lunettes chauffantes à chaleur humide, dans la prise en charge des pathologies de la surface oculaire en France

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Summary

Introduction

Eyelid hygiene, including massage and warm compresses, is an important part of the treatment and prevention of Meibomian gland dysfunction (MGD). Although effective, it requires active participation of the patient and lacks standardisation. Blephasteam® is a medical device designed to warm and humidify the eyelid with heating glasses, in order to liquify meibum, thus relieving symptoms and preventing relapse.

Materials and methods

The ESPOIR study (Evaluation of the Satisfaction of Patients with Management of Ocular Surface Diseases) presented herein was designed to evaluate the safety and efficacy of this medical device in patients with MGD. A total of 28 French centers participated in the study. One hundred and two patients presenting with symptomatic dysfunction or Meibomian-related dry eye underwent two sessions per day with the eyelid warming device and recorded diary entries on a number of parameters every 2 days for the first week and then weekly for the remaining 2 weeks. Patients were assessed on days 0 and 21.

Results

Symptomatology, as recorded on a visual analogue scale (VAS) by the investigator (the primary efficacy variable) was significantly (P < 0.001) improved at the end of the study (59.97, 95% CI 55.64–64.30 vs. 39.71, 95% CI 34.78–44.65 on Days 0 and 21 respectively), as was the mean symptoms score (mean decrease of 19.93 ± 22.15 VAS units; P < 0.001), hyperemia score (–1.57 ± 1.96 and –1.45 ± 1.85; P < 0.001, in the worse and contralateral eye respectively), and quality of meibum (mean –4.03 ± 3.08; P < 0.001 and –3.32 ± 3.20; P < 0.01, in the worse and contralateral eye respectively). More than twice as many reported their symptoms had improved or disappeared compared with those whose symptoms had not changed or had worsened. Global symptomatology, as assessed by the patients, declined throughout the study, and a large majority of patients were satisfied or very satisfied with the treatment. Clear vision and blinking were not impaired during use of the eyelid warming device, which insures proper spreading of the tear film, and patients were able to continue daily activities such as reading and watching television. No adverse events were reported, and there were no changes in intraocular pressure or visual acuity. Safety was rated as satisfactory or very satisfactory by more than 95% of the investigators.

Conclusion

The study suggests that the eyelid warming device is safe and effective in reducing ocular discomfort and symptoms in MGD.

Résumé

Introduction

L’hygiène des paupières incluant le massage et l’apport de chaleur par compresses chaudes, est un élément important de la prévention et du traitement des dysfonctions des glandes de Meibomius. Bien qu’efficace cette technique implique une participation active du patient et souffre de manque de standardisation. Blephasteam® est un dispositif médical ; les lunettes chauffantes, délivrent une chaleur humide constante sur les paupières afin de liquéfier le meibum et permettre un soulagement des symptômes et la prévention des rechutes.

Matériel et méthodes

L’étude ESPOIR (Évaluation de la satisfaction des patients vis-à-vis de la prise en charge des pathologies de surface oculaire) présentée, ici, avait pour objectif d’évaluer l’efficacité et la tolérance de ce dispositif médical chez les patients souffrant de dysfonctionnement des glandes de Meibomius (MGD). Un total de 28 centres français ont participé à l’étude. Cent deux patients présentant un dysfonctionnement symptomatique ou une sécheresse oculaire liée aux glandes de Meibomius ont été inclus. Les patients ont bénéficié de deux sessions quotidiennes de dispositif médical et ont recueilli sur un agenda personnel, un ensemble de paramètres, tous les deux jours la première semaine et ensuite de façon hebdomadaire pour les deux semaines restantes.

Résultats

La symptomatologie évaluée à l’aide d’une échelle visuelle analogique (EVA) par l’investigateur (critère principal) s’est montrée significativement (p < 0,001) améliorée en fin d’étude (59,97, 95 % CI 55,64–64,30 vs. 39,71, 95 % CI 34,78–44,65 à j0 et j21 respectivement), en parallèle avec le score moyen de symptômes (diminution moyenne de 19,93 ± 22,15 mm sur l’EVA ; p < 0,001), le score d’hyperémie (–1,57 ± 1,96 et –1,45 ± 1,85 ; p < 0,001 pour respectivement, l’œil le plus atteint et l’œil controlatéral), et la qualité du meibum (diminution moyenne de –4,03 ± 3,08 ; p < 0,001 et –3,32 ± 3,20 ; p < 0,01, pour respectivement, l’œil le plus atteint et l’œil controlatéral). Plus du double de patients ont rapporté que leurs symptômes s’étaient améliorés ou avaient disparu par rapport à ceux dont les symptômes étaient soit inchangés, soit aggravés. La symptomatologie globale évaluée par les patients a diminué tout au long de l’étude et une large majorité de patients ont été satisfaits ou très satisfaits du traitement. Avec les lunettes, la vision n’est pas réduite et le clignement des paupières est maintenu, ce qui favorise l’étalement du film lacrymal. Les patients ont pu continuer leurs activités quotidiennes comme la lecture ou le fait de regarder la télévision. Aucun effet indésirable n’a été rapporté et il n’y a pas eu de modifications de la pression intra-oculaire ou de l’acuité visuelle. La tolérance a été jugée satisfaisante ou très satisfaisante par plus de 95 % des investigateurs.

Conclusion

Cette étude suggère que le dispositif médical est efficace et bien toléré dans l’amélioration du confort oculaire et des symptômes liés aux MGD.

Introduction

The meibomian glands are modified sebaceous glands located in the tarsal plate of the eyelids. Their role is to actively synthesise and secrete lipids and proteins that promote stability of the tear film and, most importantly, to prevent its evaporation [1]. Meibomian gland dysfunction (MGD) is defined as a chronic, diffuse abnormality of the meibomian glands, commonly characterised by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion [2]. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease [2]. MGD is a major cause of dry eye disease [1]. Ocular symptoms include mild to persistent irritation, itching, burning, stinging, light sensitivity and blurred vision. The feeling of having the eyelids glued shut on waking is a major discomfort. The symptoms of MGD are a consequence of impaired quality or quantity of meibum provided to the ocular surface. When the meibomian acini become blocked or their function is otherwise impaired, the meibum produced has a deteriorated lipid structure with more branched chain fatty acids and cholesterol. This meibum has poorer physicochemical properties (more waxy and viscous) and is less effective in maintaining the tear film [3].

Treatments options for MGD include lid hygiene, lubricants, topical or systemic antibiotics, and topical steroids [4]. Lid hygiene, which includes eyelid warming using warm compresses, infrared or hot air sources and mechanical lid hygiene, is the mainstay of treatment. In patients with MGD the melting point of the meibum is raised from 32 ˚C to > 35 ˚C [5]. The aim of lid hygiene is to warm the eyelids up to 40 ˚C, to melt the meibum and facilitate its clearance through the application of pressure or massage. However, non-compliance with this approach is common due to the complexity of this process, inadequate eyelid warming and the requirement for long-term treatment.

Eyelid warming devices have been developed to overcome these barriers to treatment. Encouraging results have been observed with a novel eyelid warming device (Blephasteam®; Laboratoires Théa, Clermont-Ferrand, France), with improvements in tear film lipid layer thickness and ocular comfort in normal subjects and patients with dry eye disease [6], [7] and may offer benefits over traditional compress therapy [8].

The aim of this multicentre study (Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases, ESPOIR) was to collect information from patients and ophthalmologists in order to investigate the efficacy and safety of the eyelid warming device in the management of patients with MGD in France. The ESPOIR study was performed in Paris and Clermont-Ferrand, and the ESPOIR extension study was performed in 25 centres in France.

Section snippets

Methods

This prospective, open-label, uncontrolled, phase IV, study took place in a total of 28 centres in France. The ESPOIR study was conducted in accordance with Good Clinical Practice guidelines (ICH Guidelines and European directive 2001/20/CE) and the Declaration of Helsinki (2004). All patients provided written informed consent prior to participating in the study which was approved on March 2nd 2010 by the Ethics Committee “Comité de protection des personnes île-de-France V”.

The primary

Inclusion and exclusion criteria

Patients with symptomatic MGD and/or dry eye related to MGD, which had been stable for at least one month, were eligible for inclusion in the study. Exclusion criteria included any of the following in either eye: active pathology requiring a change in ocular treatment within the previous month; history of surgical events, including refractive surgery, within the last 6 months; any ocular anomaly interfering with the ocular surface; best far corrected visual acuity (VA)  1/10; history of trauma

Study treatment

The eyelid warming device under investigation consists of a pair of glasses, the eyepieces of which create a warm moist chamber (Fig. 1). This latent heat melts the meibum facilitating its release from the glands. The alternating current-supplied device is plugged in for 15 minutes before use; coloured lights indicate when the device is ready for use. Two disposable rings moistened with drinking water are inserted into each eyepiece, and the device worn for 10 minutes; the device times this

Efficacy parameters

At study entry (Visit 1; Day 0) investigators recorded details of patients’ ocular medical history and treatment and ocular symptoms (recorded on a visual analogue scale) and signs (slit lamp examination, lid margin examination, visual acuity, tear osmolarity, and intraocular pressure). Patients were reassessed at the end-of-study visit, which took place at 21 days ± 2 days (Visit 2; Day 21). Details of the study procedures conducted at Visits 1 and 2 are included in Table 1.

Patients were asked

Safety parameters

The safety of the eyelid warming device was assessed using corrected VA and overall assessment by investigators. Best far corrected VA was measured for both eyes separately using a Snellen chart on Days 0 and 21. Investigators were asked the following question on Day 21, “After 21 days of use, how do you consider the safety of the eyelid warming device?” Responses were measured on a scale of 0 to 3 where: 0 = Very satisfactory; 1 = Satisfactory; 2 = Unsatisfactory; 3 = Very unsatisfactory.

Intraocular

Statistical analysis

The efficacy and safety results were evaluated using the intention-to-treat (ITT) dataset, that was all patients enrolled in the study for whom there was evidence that they used the eyelid warming device and for whom any follow-up information was available.

Descriptive statistics were used for the quantitative variables and frequency distribution for the categorical variables. The symptomatology VAS between baseline (Day 0, before device application) and each post-baseline value were compared

Results

A total of 102 patients (36 males, 66 females) with a mean age of 54.5 years ± 20.8 from 28 centres in France were eligible for inclusion in this study. The mean time since MGD diagnosis was 38.0 ± 49.2 months. MGD was the primary diagnosis in 49 patients and a secondary diagnosis in 53 patients (33 acne rosacea, 3 atopy, 1 psoriasis, 3 seborrheic dermatitis, 1 seborrheic dermatitis and acne rosacea, 12 others who had a secondary diagnosis of MGD), but without a determined cause (such as acne

Primary efficacy variable

Symptomatology, as scored on the 0–100 VAS, was significantly (P < 0.001) lower on Day 21 than on Day 0 (59.97, 95% CI 55.64–64.30 vs. 39.71, 95% CI 34.78–44.65 on Days 0 and 21 respectively; 102 and 96 Patients respectively were evaluated in the intent to treat sample) (Fig. 2).

The mean symptomology score as rated by a VAS fell significantly during the course of the study (mean decrease of 19.93 ± 22.15 VAS units; P < 0.001). The proportion of patients without disturbing ocular symptoms also

Safety

There was no significant difference in corrected VA on Days 0 and 21 (mean change 0.2 ± 0.99). Overall, 95.9% (94/98) of investigators rated the safety of the eyelid warming device as satisfactory (50.0%, [49/98]) or very satisfactory (45.9% [45/98]). Of the four patients in whom the investigator rated the safety as less then satisfactory, one patient had an inflamed eyelid, one had lack of efficacy, one had missing data and no reason was recorded for the other. No adverse events were observed

Discussion

Disorders of the eyelid are among the most common pathologies encountered in routine ophthalmological practice. Despite a growing understanding of the interacting pathologies that give rise to this group of disorders [10], [11], eyelid hygiene and eyelid health in general remain the cornerstones of treatment and prevention [12]. The anatomical location of the lacrimal functional unit renders it less available to routine hygiene than the rest of the face. In patients with disorders of the

Conclusion

The eyelid warming device proved effective in decreasing ocular discomfort, ocular symptoms (such as burning and stinging, sensitivity to light), conjunctival hyperemia, eyelid symptoms and quality of the meibum compared with baseline measurements.

Patients were satisfied with their experience of the device and could continue other activities during use. The eyelid warming device is an effective device for providing warmth and humidity to the eye and appears to be a promising alternative or

Disclosure of interest

Laboratoires Thea, the manufacturer of Blephasteam®, funded the study. The authors and investigators were remunerated for their participation in the study. Dr JF Stolz provided editorial assistance in the preparation of the manuscript and this work was remunerated by Laboratoires Thea.

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1

ESPOIR study group: C. Baudouin, V. Borderie, T. Bourcier, J.-L. Bourges, D. Bremond-Gignac, H. Chenal, F. Chiambaretta, B. Cochener, J. Colin, C. Creuzot-Garcher, S. Doan, A. Ducasse, S. Fauquier, D. Flores, P. Gain, J.-L. Georges, D. Giffon, T. Hoang-Xuan, M. Labetoulle, K. Laouar, S. Maes-Castellarin, S. Mainguy, C. Meuriot-Tuil, S. Morax, B. Mortemousque, M. Muraine, P.-J. Pisella, B. Rysanek, P.-Y. Robert, S. Roncin, J.-F. Rouland, F. Roux, C. Speeg, G. Touvron-Reynier and Y. Uteza.

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