Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02848222
• Collaborator: Bruder Healthcare Company (Other)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 17
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Discomfort; Dry Eye Disease; Meibomian Gland Dysfunction	Device: Bruder Moist Heat Compress; Other: Washcloth	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Twice Daily Application of Bruder compress Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal	Device: Bruder Moist Heat Compress; Other Names: Bruder mask
Experimental: Once Daily Application of Bruder compress Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Device: Bruder Moist Heat Compress; Other Names: Bruder mask
Sham Comparator: Twice Daily Application of warm washcloth Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal	Other: Washcloth

Outcome Measures

Primary Outcome Measures

1. Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) [Baseline through 1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• Provide informed consent and authorization to disclose protected health information

• Have habitual contact lens corrected visual acuity in each eye of at least 20/30

• Willing to comply with protocol

• 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

Exclusion Criteria:

• 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

• Pregnant by self-report

• Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation including anterior blepharitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35226

Sponsors and Collaborators

• University of Alabama at Birmingham
• Bruder Healthcare Company

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jul 27, 2016
• Statistical Analysis Plan - Mar 6, 2018

More Information

Publications

None provided.

• Responsible Party: Jason Nichols, principal investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02848222
• Other Study ID Numbers: BR1016
• First Posted: Jul 28, 2016
• Last Update Posted: May 17, 2018
• Last Verified: May 1, 2018

• Keywords provided by Jason Nichols, principal investigator, University of Alabama at Birmingham: contact lens discomfort; dry eye disease; meibomian gland dysfunction; Bruder mask
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Meibomian Gland Dysfunction

Study Results

Participant Flow

Arm/Group Title	Group 1: Twice Daily Application of Bruder Compress	Group 2: Once Daily Application of Bruder Compress	Group 3: Twice Daily Application of Warm Washcloth
Arm/Group Description	Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal	Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
Period Title: Overall Study
STARTED	25	18	17
COMPLETED	18	17	17
NOT COMPLETED	7	1	0

Baseline Characteristics

Arm/Group Title	Group 1: Twice Daily Application of Bruder Compress	Group 2: Once Daily Application of Bruder Compress	Group 3: Twice Daily Application of Warm Washcloth	Total
Arm/Group Description	Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal	Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal	Total of all reporting groups
Overall Participants	17	17	17	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (8)	32 (12)	36 (11)	33 (10)
Sex: Female, Male (Count of Participants)
Female	16 94.1%	17 100%	17 100%	50 98%
Male	1 5.9%	0 0%	0 0%	1 2%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 11.8%	1 5.9%	2 11.8%	5 9.8%
Native Hawaiian or Pacific Islander	0 0%	2 11.8%	0 0%	2 3.9%
Caucasian	10 58.8%	8 47.1%	8 47.1%	26 51%
African American	5 29.4%	6 35.3%	7 41.2%	18 35.3%
Region of Enrollment (participants) [Number]
United States	17 100%	17 100%	17 100%	51 100%
Comfortable Contact Lens Wear Time (hours per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours per day]	7.8 (3.0)	8.0 (3.9)	5.9 (3.2)	7.3 (3.4)

Outcome Measures

1. Primary Outcome

Title	Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)
Time Frame	Baseline through 1 month

Outcome Measure Data

Analysis Population Description

In Gr1, 25 subjects were randomized, 18 subjects completed, 7 discontinued early and 1 subject's data was not used due to poor compliance resulting in 17 subjects analyzed. In Gr2, 18 subjects were randomized and 17 completed. In Gr3, 17 subjects were randomized and completed.

Arm/Group Title	Group 1: Twice Daily Application of Bruder Compress	Group 2: Once Daily Application of Bruder Compress	Group 3: Twice Daily Application of Warm Washcloth
Arm/Group Description	Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal	Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
Measure Participants	17	17	17
Mean (Standard Deviation) [hours per day]	9.2 (2.8)	8.5 (3.6)	7.1 (2.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Twice Daily Application of Bruder Compress, Group 2: Once Daily Application of Bruder Compress, Group 3: Twice Daily Application of Warm Washcloth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	Threshold for significance was p < 0.05
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Baseline through 1 month
Arm/Group Title	Group 1: Twice Daily Application of Bruder Compress		Group 2: Once Daily Application of Bruder Compress		Group 3: Twice Daily Application of Warm Washcloth
Arm/Group Description	Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal		Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal		Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
All Cause Mortality
	Group 1: Twice Daily Application of Bruder Compress		Group 2: Once Daily Application of Bruder Compress		Group 3: Twice Daily Application of Warm Washcloth
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/18 (0%)		0/17 (0%)
Serious Adverse Events
	Group 1: Twice Daily Application of Bruder Compress		Group 2: Once Daily Application of Bruder Compress		Group 3: Twice Daily Application of Warm Washcloth
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/18 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Twice Daily Application of Bruder Compress		Group 2: Once Daily Application of Bruder Compress		Group 3: Twice Daily Application of Warm Washcloth
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/18 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.