Trial Outcomes & Findings for Accommodative Relief for Uncomfortable Non-Presbyopes (NCT NCT03544216)

Last Updated: 2019-02-15

Results Overview

After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Single Vision First Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks. Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks	Multifocal First Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data regarding gender of participants were not recorded for this study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Vision First n=42 Participants Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks. Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks	Multifocal First n=42 Participants Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks	Total n=84 Participants Total of all reporting groups
Age, Continuous	34.4 years STANDARD_DEVIATION 3.4 • n=42 Participants	34.5 years STANDARD_DEVIATION 3.1 • n=42 Participants	34.4 years STANDARD_DEVIATION 3.2 • n=84 Participants
Sex: Female, Male Female	—	—	0 Participants Data regarding gender of participants were not recorded for this study.
Sex: Female, Male Male	—	—	0 Participants Data regarding gender of participants were not recorded for this study.
Race/Ethnicity, Customized Race/Ethnicity Data Not Collected for This Study	—	—	0 Participants Data regarding race/ethnicity were not analyzed for this study.
Contact Len Dry Eye Questionnaire-8 (CLDEQ-8) Score with Habitual Contact Lenses	19.0 scores on a scale STANDARD_DEVIATION 4.5 • n=42 Participants	19.1 scores on a scale STANDARD_DEVIATION 5.0 • n=42 Participants	19.0 scores on a scale STANDARD_DEVIATION 4.7 • n=84 Participants
Spherical Equivalent Refractive Error (Right Eye)	-4.2 diopters STANDARD_DEVIATION 2.1 • n=42 Participants	-4.0 diopters STANDARD_DEVIATION 2.0 • n=42 Participants	-4.1 diopters STANDARD_DEVIATION 2.1 • n=84 Participants
Spherical Equivalent Refractive Error (Left Eye)	-4.2 diopters STANDARD_DEVIATION 2.0 • n=42 Participants	-4.1 diopters STANDARD_DEVIATION 2.0 • n=42 Participants	-4.2 diopters STANDARD_DEVIATION 2.0 • n=84 Participants
Accommodative Lag with 2 Diopter Target	0.9 diopters STANDARD_DEVIATION 0.5 • n=42 Participants	0.8 diopters STANDARD_DEVIATION 0.7 • n=42 Participants	0.9 diopters STANDARD_DEVIATION 0.6 • n=84 Participants
Accommodative Lag with 4 Diopter Target	1.3 diopters STANDARD_DEVIATION 0.9 • n=42 Participants	1.5 diopters STANDARD_DEVIATION 0.7 • n=42 Participants	1.4 diopters STANDARD_DEVIATION 0.8 • n=84 Participants

PRIMARY outcome

Timeframe: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)

Outcome measures

Outcome measures
Measure	CLDEQ-8 With Multifocal Contact Lens n=84 Participants Mean CLDEQ-8 score across both groups (single vision first and multifocal first)(n = 84) with the multifocal contact lens	CLDEQ-8 With Single Vision Contact Lens n=84 Participants Mean CLDEQ-8 score across both groups treatment groups (single vision first and multifocal first)(n = 84) with the single vision contact lens	CLDEQ-8 With Habitual Contact Lenses n=84 Participants Mean CLDEQ-8 score across both groups (single vision first and multifocal first)(n=84) at baseline with each subject's habitual contact lenses
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	14.3 scores on a scale Standard Deviation 7.1	12.8 scores on a scale Standard Deviation 6.6	19.0 scores on a scale Standard Deviation 4.7

Adverse Events

Single Vision Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multifocal Contact Lens

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

Erin Rueff, OD, PhD

Marshall B. Ketchum University (The Ohio State University during study data collection)

Phone: 7654145644

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place