Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Accommodative Relief for Uncomfortable Non-Presbyopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03544216
Recruitment Status : Completed
First Posted : June 1, 2018
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Erin Rueff, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Asthenopia
Interventions Device: Multifocal Contact Lens
Device: Single Vision Contact Lens
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Vision First Multifocal First
Hide 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
Arm/Group Title Single Vision First Multifocal First Total
Hide 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 Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
34.4  (3.4) 34.5  (3.1) 34.4  (3.2)
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female 0
Male 0
[1]
Measure Description: Data regarding gender of participants were not recorded for this study
[2]
Measure Analysis Population Description: Data regarding gender of participants were not recorded for this study.
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Data Not Collected for This Study Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Description: Data regarding race/ethnicity were not analyzed for this study.
[2]
Measure Analysis Population Description: Data regarding race/ethnicity were not analyzed for this study.
Contact Len Dry Eye Questionnaire-8 (CLDEQ-8) Score with Habitual Contact Lenses   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 42 participants 42 participants 84 participants
19.0  (4.5) 19.1  (5.0) 19.0  (4.7)
[1]
Measure Description: Min-Max range: 0-37 points Higher point values indicate more/worse symptoms
Spherical Equivalent Refractive Error (Right Eye)  
Mean (Standard Deviation)
Unit of measure:  Diopters
Number Analyzed 42 participants 42 participants 84 participants
-4.2  (2.1) -4.0  (2.0) -4.1  (2.1)
Spherical Equivalent Refractive Error (Left Eye)  
Mean (Standard Deviation)
Unit of measure:  Diopters
Number Analyzed 42 participants 42 participants 84 participants
-4.2  (2.0) -4.1  (2.0) -4.2  (2.0)
Accommodative Lag with 2 Diopter Target   [1] 
Mean (Standard Deviation)
Unit of measure:  Diopters
Number Analyzed 42 participants 42 participants 84 participants
0.9  (0.5) 0.8  (0.7) 0.9  (0.6)
[1]
Measure Description: Accommodative Lag was measured with an autorefractor while the the subject was viewing a visual target at at 50 cm (2 diopter visual demand) and the single vision study lens. Accommdative lag is reported with the single vision lens only because the multifocal lens induces power changes that affect autorefractor measurements.
Accommodative Lag with 4 Diopter Target   [1] 
Mean (Standard Deviation)
Unit of measure:  Diopters
Number Analyzed 42 participants 42 participants 84 participants
1.3  (0.9) 1.5  (0.7) 1.4  (0.8)
[1]
Measure Description: Accommodative Lag was measured with an autorefractor while the the subject was viewing a visual target at at 25 cm (4 diopter visual demand) and the single vision study lens. Accommdative lag is reported with the single vision lens only because the multifocal lens induces power changes that affect autorefractor measurements.
1.Primary Outcome
Title Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 84 84 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
14.3  (7.1) 12.8  (6.6) 19.0  (4.7)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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 [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments Analysis controlled for order, visit, and repeated measures.
Method Generalized linear model
Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments Analysis controlled for order, visit, and repeated measures.
Method Generalized linear model
Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments Analysis controlled for order, visit, and repeated measures.
Method Generalized linear model
Comments [Not Specified]
Show Statistical Analysis 5 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments Analysis controlled for order, visit, and repeated measures
Method Generalized linear model
Comments [Not Specified]
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

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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Vision Contact Lens Multifocal Contact Lens
Hide 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 (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/84 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Vision Contact Lens Multifocal Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/84 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Vision Contact Lens Multifocal Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/84 (0.00%) 
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.
Results Point of Contact
Name/Title: Erin Rueff, OD, PhD
Organization: Marshall B. Ketchum University (The Ohio State University during study data collection)
Phone: 7654145644
Responsible Party: Erin Rueff, Ohio State University
ClinicalTrials.gov Identifier: NCT03544216     History of Changes
Other Study ID Numbers: 2016H0382-60058303
First Submitted: January 12, 2017
First Posted: June 1, 2018
Results First Submitted: December 28, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019