Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
Phase: NA
Conditions: Contact Lens Discomfort, Dry Eye Disease, Meibomian Gland Dysfunction
Sponsor: University of Alabama at Birmingham

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Pilot Study for Investigating the Effect of the 
Bruder Eye Hydrating Compress on Contact Lens 
Discomfort in Contact Lens Wearers  
 
PRINCIPAL INVESTIGATOR: 
JASON J. NICHOLS, OD MPH PHD 
CO-INVESTIGATOR: 
ANNA F. ABLAMOWICZ, OD 
 
 
 
UNIVERSITY OF ALABAMA AT BIRMINGHAM 
SCHOOL OF OPTOMETRY 
1716 UNIVERSITY BLVD 
BIRMINGHAM, AL 35294-0010 


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Background 
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 are constantly being 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 put forth dryness as a primary reason for contact lens intolerance.3 Indeed, 
when a contact lens is placed on the eye, the tear film structure becomes altered resulting in a 
pre-lens thinned lipid layer and a post-lens thinned aqueous layer.4 As a result of this disruption 
from the contact lens, the tear film tends to have an increased rate of evaporation leading to poor 
wetting on the surface of the contact lens and inadequate lubrication on the surface of the eye. 
This is further exacerbated if the patient has an already unstable lipid layer due to the presence 
of meibomian gland dysfunction (MGD). 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 lead to contact lens discomfort.5  
Contact lens wearers often report dry eye symptoms and show signs of MGD including gland 
atrophy, thinned lipid layer, and increased tear film instability.6-8 It has been shown that in many 
patients with intolerance to contact lenses, MGD has been observed. Therefore, 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.9-11 With good patient 
compliance, warm compresses have been shown to be an adequate supplemental therapy for 
MGD as the heat softens meibum in glands that are obstructed allowing for secretion into the tear 
film. Many methods of applying heat to the eyelids for treatment of MGD exist; however, the 
results of the different methods can vary based on the heating method, how long the compress is 
applied, and whether the compress remains hot for the duration of application. Because of the 
sometimes seemingly ineffectiveness of the therapy due to variation in methods and no accepted 
standard, patient compliance for home therapy often wanes and further reduces the likelihood of 
successful treatment. Therefore, the purpose of this study is to assess the potential benefits of 
using the Bruder Moist Heat Compress, a warm compress capable of maintain heat effectively, in 
contact lens wearers with MGD. 
Study Design & Endpoints 
This will be a prospective, three-arm, randomized controlled study to evaluate the benefits of 
using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable 
wearing time by assessing improvement in MG function and comfortable contact lens wearing 
time after one month of daily warm compress application. All subjects will undergo examination 
to determine eligibility and capture baseline status. Study endpoints will be evaluated after one 
month.  
Thirty adults who currently wear contact lenses, who report reduced contact lens wear time will 
be enrolled in the study. Subjects will be randomized to either one of two treatment arms or a 
control arm with approximately ten subjects per group; that is, subjects will be randomized to one 
of the following study arms: 

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1) Application of Bruder Moist Heat Compress twice daily for one month (ten minute 
application in the morning prior to contact lens insertion and ten minute application in 
the evening after lens removal) 
2) Application of Bruder Moist Heat Compress once daily for one month (ten minute 
application in the evening after lens removal) 
3) Application of warm wash cloth twice daily (ten minute application each time) for one 
month (control group) 
Subjects will be seen for three study visits over a period of four weeks according to the following 
visit schedule:  
 
Visit 1 (Screening & Randomization, Day 1) 
 
Visit 2 (Day 15 ± 2 days) 
 
Visit 3 (Final Visit, Day 29 ± 1 day) 
The procedures to be performed during the visits include: 
1. Questionnaires: CLDEQ long form, SPEED, OSDI 
2. Medical and Ophthalmic History  
3. Habitual visual acuity with contact lenses 
4. Contact Lens fit assessment  
5. LipiView to measure tear film thickness 
6. Slit lamp examination 
7. Tear film break up time 
8. Corneal Staining 
9. MG assessment 
10. Meibography 
11. Corneal Topography 
Each visit will take approximately 45 minutes. Subjects will be instructed to apply the Bruder Moist 
Heat Compress after removal or prior to insertion of contact lenses. Subjects will heat the 
compress according to the instructions on the package, namely: heat for twenty-five seconds in 
the microwave, and depending on the microwave wattage increase by increments of five seconds 
to not exceed a total of thirty-five seconds. Once heated, subjects will apply the compress to 
closed eyelids for ten minutes. During the treatment period, subjects will complete a daily diary 
that captures insertion and removal time of contact lenses, as well as the time comfortable contact 
lens wear ends. Diaries will also be used to ensure subject compliance of application of the Bruder 
compress.  
Study Objectives 
Primary Objective: To show that daily application of the Bruder Moist Heat Compress in 
subjects with MGD who experience CL discomfort can result in an increase in 
comfortable contact lens wear time 
Secondary Objective: To compare the efficacy of once daily application of the Bruder 
Moist Heat Compress versus twice daily application 

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Tertiary Objective: To show that the Bruder Moist Heat Compress is an effective 
treatment for improving meibomian gland function in symptomatic contact lens wearers 
Study Endpoints 
Primary: Mean change from baseline in the duration of subject-reported comfortable 
contact lens daily wear time (hours per day) at the week four visit 
Secondary: Mean change in comfortable contact lens wear time (hours per day) in twice 
daily application group compared to once daily application group 
Tertiary: Mean change in total meibomian gland score in treatment groups using the 
Bruder Moist Heat Compress compared to controls from baseline to four weeks 
Inclusion Criteria: 
1. 18 years or older 
2. Provide informed consent and authorization to disclose protected health information 
3. Have habitual contact lens corrected visual acuity in each eye of at least 20/30  
4. Willing to comply with protocol 
5. Wear soft daily contact lenses for total wear time of at least 4 hours a day and at least 4 
days a week on average over at least a 30 day period before enrollment 
6. Have a diagnosis of Contact Lens Dry Eye based on the CLDEQ results 
7. Have at least a 2 hour difference between overall wear time and comfortable wear time 
of contact lenses 
8. Assess that the contact lens fit/material/disinfection solution are acceptable and not 
reasons for CL discomfort 
Exclusion Criteria: 
1. Have any uncontrolled systemic disease that in the investigator’s opinion could be 
expected to interfere with the study, for example, conditions associated with dry eye 
disease 
2. Pregnant by self-report 
3. Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation 
including anterior blepharitis  
4. Have a clinically significant ophthalmic abnormality noted during examination or per 
subject history 
5. Have changed the brand of contact lenses or care solutions within 30 days prior to 
screening or anticipates the need to change current type or brand of contact lenses or 
care solutions 
6. Any overnight wear of contact lenses or daily disposable contact lenses 
7. Require use of prescribed topical ophthalmic medications 
8. Participation in a clinical trial in the past 30 days 
9. Any previous refractive or corneal surgery (e.g., PRK, LASIK, radial keratotomy,etc.) 
10. In the opinion of the investigator, be unwilling or unable to comply with the study protocol 
11. Have temporary and/or permanent punctal plugs in either or both eyes 
12. Have initiated or altered the dosage of omega-3 dietary supplements in the past 30 days 

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References 
1. 
Cope JR, Collier SA, Rao MM, R. C, G.L. M, K. R. Contact Lens Wearer Demographics 
and Risk Behaviors for Contact Lens-Related Eye Infections, United States, 2014. 2015; 
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6432a2.htm. Accessed September 16, 
2015. 
2. 
Rumpakis J. New Data on Contact Lens Dropouts: An International Perspective. 2010; 
http://www.reviewofoptometry.com/content/d/contact_lenses_and_solutions/c/18929/. 
Accessed September 16, 2015. 
3. 
Dumbleton K, Caffery B, Dogru M, et al. The TFOS International Workshop on Contact 
Lens Discomfort: report of the subcommittee on epidemiology. Invest Ophthalmol Vis Sci. 
2013;54(11):Tfos20-36. 
4. 
Craig JP, Willcox MD, Argueso P, et al. The TFOS International Workshop on Contact 
Lens Discomfort: report of the contact lens interactions with the tear film subcommittee. 
Invest Ophthalmol Vis Sci. 2013;54(11):Tfos123-156. 
5. 
Knop E, Knop N, Millar T, Obata H, Sullivan DA. The International Workshop on 
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Pathophysiology of the Meibomian Gland. Investigative Ophthalmology & Visual Science. 
2011;52(4):1938-1978. 
6. 
Nichols JJ, Sinnott LT. Tear film, contact lens, and patient-related factors associated with 
contact lens-related dry eye. Invest Ophthalmol Vis Sci. 2006;47(4):1319-1328. 
7. 
Young G, Chalmers R, Napier L, Kern J, Hunt C, Dumbleton K. Soft contact lens-related 
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8. 
Arita R, Itoh K, Inoue K, Kuchiba A, Yamaguchi T, Amano S. Contact lens wear is 
associated with decrease of meibomian glands. Ophthalmology. 2009;116(3):379-384. 
9. 
Geerling G, Tauber J, Baudouin C, et al. The International Workshop on Meibomian Gland 
Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian 
Gland Dysfunction. Investigative Ophthalmology & Visual Science. 2011;52(4):2050-
2064. 
10. 
Goto E, Endo K, Suzuki A, Fujikura Y, Tsubota K. Improvement of tear stability following 
warm compression in patients with meibomian gland dysfunction. Adv Exp Med Biol. 
2002;506(Pt B):1149-1152. 
11. 
Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following 
treatment with warm compresses in patients with meibomian gland dysfunction. Eye 
Contact Lens. 2003;29(2):96-99.