Trial Outcomes & Findings for Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers (NCT NCT02848222)

NCT ID: NCT02848222

Last Updated: 2018-05-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline through 1 month
• Results posted on: 2018-05-17

Participant Flow

Participant milestones

Measure	Group 1: 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	Group 2: Once Daily Application of Bruder Compress Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Group 3: 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
Overall Study STARTED	25	18	17
Overall Study COMPLETED	18	17	17
Overall Study NOT COMPLETED	7	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group 1: Twice Daily Application of Bruder Compress n=17 Participants 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	Group 2: Once Daily Application of Bruder Compress n=17 Participants Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Group 3: Twice Daily Application of Warm Washcloth n=17 Participants 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 n=51 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 8 • n=5 Participants	32 years STANDARD_DEVIATION 12 • n=7 Participants	36 years STANDARD_DEVIATION 11 • n=5 Participants	33 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	50 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Caucasian	10 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Race · African American	5 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	17 participants n=5 Participants	51 participants n=4 Participants
Comfortable Contact Lens Wear Time	7.8 hours per day STANDARD_DEVIATION 3.0 • n=5 Participants	8.0 hours per day STANDARD_DEVIATION 3.9 • n=7 Participants	5.9 hours per day STANDARD_DEVIATION 3.2 • n=5 Participants	7.3 hours per day STANDARD_DEVIATION 3.4 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline through 1 month

Population: 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.

Outcome measures

Measure	Group 1: Twice Daily Application of Bruder Compress n=17 Participants 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	Group 2: Once Daily Application of Bruder Compress n=17 Participants Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal	Group 3: Twice Daily Application of Warm Washcloth n=17 Participants 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
Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)	9.2 hours per day Standard Deviation 2.8	8.5 hours per day Standard Deviation 3.6	7.1 hours per day Standard Deviation 2.8

Adverse Events

Group 1: Twice Daily Application of Bruder Compress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2: Once Daily Application of Bruder Compress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3: Twice Daily Application of Warm Washcloth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jason Nichols

University of Alabama at Birmingham

Phone: 205-975-3497

Email: jjn@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place