Effect of the Bruder moist heat eye compress on contact lens discomfort in contact lens wearers: An open-label randomized clinical trial
Introduction
An estimated 40.9 million people in the United States aged 18 or older wear contact lenses [1]. Though newer and healthier contact lens materials have been developed, discomfort remains the top reason for contact lens discontinuation and dropout rates are estimated to be as high as 15.9% in the United States [2]. The International Workshop on Contact Lens Discomfort published in 2013 concluded from a thorough review of the literature that discomfort and dryness are the primary reasons for contact lens intolerance [3]. Indeed, when a contact lens is placed on the eye, the tear film is split into pre- and post-lens tear films. As a result of this disruption from the contact lens, the tear film tends to have an increased rate of evaporation which is accompanied by poor wetting on the surface of the contact lens and inadequate lubrication on the surface of the eye [4,5]. This is further exacerbated if the patient has an already unstable lipid layer due to the presence of meibomian gland dysfunction (MGD) [6,7]. MGD is considered by many to be the leading cause of dry eye disease throughout the world, and is a chronic and progressive condition that can contribute to a poor quality lipid layer and contact lens discomfort [8,9].
Contact lens wearers often report dry eye symptoms and show signs of MGD including gland atrophy, thinned lipid layer, and increased tear film instability [7,10,11]. Korb and Henriquez found evidence of MGD in 36.6% of symptomatic contact lens wearers [9]. Another study by Ong and Larke that enrolled both contact lens wearers and controls found MGD in 30% of the contact lens wearers compared to only 20% of controls [12]. Consequently, treatment of MGD may support functioning of the meibomian glands and lead to improvement in patient contact lens comfort. Warm compresses are a commonly prescribed treatment method for applying localized heat to the meibomian glands to improve secretion [[13], [14], [15]]. With good patient compliance, warm compresses have been shown to be an adequate supplemental therapy for MGD as the heat softens meibum in glands allowing for secretion from the gland orifice. A study by Olson et al. demonstrated that a warm compress applied to the eyelids increased tear lipid layer thickness by increasing meibum secretion from the glands [15]. Due to the disruption to the tear film and lipid layer that results from a contact lens on the surface of the eye, it was hypothesized that applying a warm compress to the eyelids to improve functioning of the meibomian glands would result in increased meibum secretion and improve comfortable contact lens wear time. Therefore, the purpose of this study was to assess the potential benefits of using the Bruder Moist Heat Eye Compress (Bruder Healthcare Company; Alpharetta, GA, USA), a warm compress capable of maintaining a stable heat profile, in contact lens wearers with contact lens-related dry eye (CLDE) [16].
Section snippets
Methods
This study was a single-center, randomized, open-label, unmasked clinical trial of the effect of the Bruder Moist Heat Compress compared to a warm washcloth in subjects with CLDE. This research was conducted in accordance with the Declaration of Helsinki with Institutional Review Board approval at the University of Alabama at Birmingham. The study was registered at ClinicalTrials.gov under the registry number NCT02848222. Informed consent was obtained from all subjects after explanation of the
Results
Sixty subjects were enrolled and randomized in the study; however, fifty-one subjects completed the study and were included in the data analyses. Seven subjects withdrew from the study due to personal issues, one was withdrawn due to poor compliance, and one was lost to follow up. This left seventeen subjects in Group 1 (using the Bruder Moist Heat Compress once a day), seventeen subjects in Group 2 (using the Bruder Moist Heat Compress twice a day), and seventeen subjects in Group 3 (using a
Discussion
Due to the disruption that occurs to the tear film and lipid layer during contact lens wear, it was hypothesized that a warm compress applied to the eyelids could facilitate lipid secretion, stabilize the tear film, and be effective in treating contact lens dry eye and discomfort. This study investigated whether application of a commercially available moist heat compress, the Bruder Moist Heat Eye Compress, led to improvement in comfortable contact lens wear time in subjects classified as
Funding
This study was sponsored by Bruder Healthcare Company, Georgia, USA.
Alcon (JJN-research, JJN-consultant), Bruder Healthcare (research; KKN & PMK-consultant), Allergan (KKN-consultant, KKN-research), Kala pharmaceuticals (KKN-research, KKN-consultant), Olympic Ophthalmics (JJN-consultant), Shire (JJN, KKN-consultant), Johnson and Johnson Vision Care (JJN-research), Sun Pharmaceuticals (KKN-consultant), ScienceBased Health (KKN-consultant), Oyster Point (KKN-consultant), Sight Sciences
Declaration of Competing Interest
Alcon (JJN-research, JJN-consultant), Bruder Healthcare (research; KKN & PMK-consultant), Allergan (KKN-consultant, KKN-research), Kala pharmaceuticals (KKN-research, KKN-consultant), Olympic Ophthalmics (JJN-consultant), Shire (JJN, KKN-consultant), Johnson and Johnson Vision Care (JJN-research), Sun Pharmaceuticals (KKN-consultant), ScienceBased Health (KKN-consultant), Oyster Point (KKN-consultant), Sight Sciences (KKN-consultant), Silk Technologies (KKN-consultant), Topivert
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2021, Contact Lens and Anterior EyeCitation Excerpt :The OSDI scores at baseline ranged from 13 to 66 indicating mild to moderate DED severity. Two weeks use, twice a day, has previously been shown to be an effective duration of treatment of the meibomian glands to observe improvements in symptoms and signs such as tear stability, lipid layer thickness and meibomian gland expressability, but generally not ocular surface staining or meibomian gland drop-out (Table 1) [10,12–24]. Several studies have shown immediate patient benefit from even a single session of eyelid warming [10,20,37] including in non-dry eye individuals [4,11], making this an attractive treatment option.