Accommodative Relief for Uncomfortable Non-Presbyopes

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03544216
• Collaborator: Bausch & Lomb Incorporated (Industry)
• Enrollment: 84
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

Condition or Disease	Intervention/Treatment	Phase
Asthenopia	Device: Multifocal Contact Lens; Device: Single Vision Contact Lens	N/A

Detailed Description

The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Accommodative Relief for Uncomfortable Non-Presbyopes
• Actual Study Start Date: Feb 2, 2017
• Actual Primary Completion Date: May 6, 2018
• Actual Study Completion Date: May 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.Therefore, this group will receive both study interventions.	Device: Multifocal Contact Lens; The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks; Device: Single Vision Contact Lens; The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
Experimental: 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. Therefore, this group will receive both study interventions.	Device: Multifocal Contact Lens; The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks; Device: Single Vision Contact Lens; The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks

Outcome Measures

Primary Outcome Measures

1. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score [Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Visual acuity of 20/25 or better in both eyes with habitual contact lenses

• -0.75 D or more myopic in both eyes

• -0.75 D or less astigmatism in both eyes

• Current single vision contact lens wearer who does not require a reading aid

• CLDEQ-8 score of 12 or more points with habitual contact lenses

• No history of ocular surgery or medication

• Reports digital device use of at least 3 hours per day

• No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)

• No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Optometry	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 21, 2017

More Information

Publications

None provided.

• Responsible Party: Erin Rueff, Clinical Research Optometrist and PhD Candidate, Ohio State University
• ClinicalTrials.gov Identifier: NCT03544216
• Other Study ID Numbers: 2016H0382-60058303
• First Posted: Jun 1, 2018
• Last Update Posted: Feb 15, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Erin Rueff, Clinical Research Optometrist and PhD Candidate, Ohio State University: Contact Lens; Multifocal; Accommodation; Presbyopia
• Additional relevant MeSH terms: Asthenopia

Study Results

Participant Flow

Arm/Group Title	Single Vision First	Multifocal First
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	42	42
COMPLETED	42	42
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Single Vision First	Multifocal First	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	42	42	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.4 (3.4)	34.5 (3.1)	34.4 (3.2)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Race/Ethnicity Data Not Collected for This Study	0 0%
Contact Len Dry Eye Questionnaire-8 (CLDEQ-8) Score with Habitual Contact Lenses (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	19.0 (4.5)	19.1 (5.0)	19.0 (4.7)
Spherical Equivalent Refractive Error (Right Eye) (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	-4.2 (2.1)	-4.0 (2.0)	-4.1 (2.1)
Spherical Equivalent Refractive Error (Left Eye) (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	-4.2 (2.0)	-4.1 (2.0)	-4.2 (2.0)
Accommodative Lag with 2 Diopter Target (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	0.9 (0.5)	0.8 (0.7)	0.9 (0.6)
Accommodative Lag with 4 Diopter Target (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	1.3 (0.9)	1.5 (0.7)	1.4 (0.8)

Outcome Measures

1. Primary Outcome

Title	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
Description	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
Time Frame	Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CLDEQ-8 With Multifocal Contact Lens, CLDEQ-8 With Single Vision Contact Lens, CLDEQ-8 With Habitual Contact Lenses
	Comments	Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Results of post-hoc analyses comparing scores of each lens type to one another: Habitual lens and multifocal contact lens: p <0.001 Habitual lens and single vision lens: p <0.001 Multifocal lens and single vision lens: p = 0.08
	Method	Generalized linear models
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CLDEQ-8 With Multifocal Contact Lens, CLDEQ-8 With Single Vision Contact Lens
	Comments	A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments	Analysis controlled for order, visit, and repeated measures.
	Method	Generalized linear model
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CLDEQ-8 With Multifocal Contact Lens, CLDEQ-8 With Single Vision Contact Lens
	Comments	A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7
	Comments	Analysis controlled for order, visit, and repeated measures.
	Method	Generalized linear model
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CLDEQ-8 With Multifocal Contact Lens, CLDEQ-8 With Single Vision Contact Lens
	Comments	A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3
	Comments	Analysis controlled for order, visit, and repeated measures.
	Method	Generalized linear model
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	CLDEQ-8 With Multifocal Contact Lens, CLDEQ-8 With Single Vision Contact Lens
	Comments	A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to <35 years old and 35 to 40 years old, by self report)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.047
	Comments	Analysis controlled for order, visit, and repeated measures
	Method	Generalized linear model
	Comments
Other Statistical Analysis		Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type*age group) produced the following results: p = 0.01 for MF*<35 age group compared to Single Vision (SV)*<35 age group p = 0.07 for MF*<35 age group compared to MF*>35 age group p > 0.05 for MF*<35 age group compared to Single Vision (SV)*>35 age group p > 0.05 for SV*<35 age group compared to SV*>35 age group p >0.05 for SV*<35 age group compared to MF*>35 age group p > 0.05 for MF*>35 age group compared to SV*>25 age group

Adverse Events

Time Frame	Data from potential adverse events were collected for the duration of the study for each subject. From baseline to final visit, each subject participated in the study for approximately 4-6 weeks.
Arm/Group Title	Single Vision Contact Lens		Multifocal Contact Lens
Arm/Group Description	All subjects wore the single vision (Bausch + Lomb ULTRA®) lens for approximately 2 weeks during the study.		All subjects wore the multifocal vision (Bausch + Lomb ULTRA® for Presbyopia) lens for approximately 2 weeks during the study.
All Cause Mortality
	Single Vision Contact Lens		Multifocal Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/84 (0%)
Serious Adverse Events
	Single Vision Contact Lens		Multifocal Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/84 (0%)
Other (Not Including Serious) Adverse Events
	Single Vision Contact Lens		Multifocal Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/84 (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.