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Connecting Contact Lenses and Digital Technology

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ClinicalTrials.gov Identifier: NCT02921087
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Danielle Iacono, State University of New York College of Optometry

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Asthenopia
Contact Lenses
Ocular Accommodation
Convergence, Excess
Interventions Device: Test Daily Disposable Soft Contact Lenses
Device: Control Daily Disposable Soft Contact Lenses
Enrollment 23
Recruitment Details  
Pre-assignment Details Forty five subjects were consented and screened. Twenty three were found to be eligible and randomized. Twenty two completed the study.
Arm/Group Title Test 1 Week, Followed by Control 1 Week, no Washout Control 1 Week, Followed by Test 1 Week, no Washout
Hide Arm/Group Description

Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.

Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.

Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Period Title: Overall Study
Started 12 11
Completed 12 10 [1]
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
[1]
One subject dropped out prior to 1 week of lens wear while wearing the control lens (lens 1).
Arm/Group Title Test Followed by Control Control Followed by Test Total
Hide Arm/Group Description

Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.

Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.

Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days

Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
28.83  (3.63) 25.09  (3.48) 27.04  (3.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
9
  75.0%
10
  90.9%
19
  82.6%
Male
3
  25.0%
1
   9.1%
4
  17.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
12
 100.0%
11
 100.0%
23
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
American Indian or Alaska Native
1
   8.3%
0
   0.0%
1
   4.3%
Asian
2
  16.7%
3
  27.3%
5
  21.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   8.3%
2
  18.2%
3
  13.0%
White
7
  58.3%
5
  45.5%
12
  52.2%
More than one race
1
   8.3%
1
   9.1%
2
   8.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 11 participants 23 participants
12 11 23
1.Primary Outcome
Title Subjective Symptom Improvement
Hide Description The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).
Time Frame Baseline and after 1 week of wearing each lens.
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. One week data for the primary outcome was available for 22 subjects.
Arm/Group Title Test Arm: Multifocal Soft Contact Lenses Control Arm: Single Vision Spherical Contact Lenses Baseline Symptoms
Hide Arm/Group Description:
Symptoms after one week of wearing multifocal soft spherical contact lenses.
Symptoms after one week of wearing single vision soft spherical contact lenses.
Symptoms at visit one in habitual contact lenses
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
153.9  (124.9) 100.7  (79.2) 272.13  (150.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
Comments In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments Least-squares adjusted means were obtained and compared.
2.Secondary Outcome
Title Lens Preference
Hide Description Based on two alternative forced choice method
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
Arm/Group Title Preferred Multifocal Lenses Preferred Single Vision Lenses
Hide Arm/Group Description:
Percentage of subjects who preferred the multifocal (test) lenses
Percentage of subjects who preferred the single vision (control) lenses
Overall Number of Participants Analyzed 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
7
  31.8%
15
  68.2%
3.Secondary Outcome
Title Lag of Accommodation in Study Lenses
Hide Description Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
Arm/Group Title Test Arm: Multifocal Soft Contact Lenses Control Arm: Single Vision Spherical Contact Lenses
Hide Arm/Group Description:
Lag of Accommodation while wearing multifocal soft spherical contact lenses.
Lag of Accommodation while wearing single vision soft spherical contact lenses.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Diopters
Lag at 25 cm 1.52  (0.47) 1.23  (0.57)
Lag at 40 cm 1.06  (0.60) 0.75  (0.45)
Lag at Distance 0.00  (0.43) 0.22  (0.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
Comments In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments Least-squares adjusted means were obtained and compared.
4.Secondary Outcome
Title Convergence Insufficiency Symptom Survey (CISS)
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
Arm/Group Title Test Arm: Multifocal Soft Contact Lenses Control Arm: Single Vision Spherical Contact Lenses
Hide Arm/Group Description:
Symptoms after one week of wearing multifocal soft spherical contact lenses.
Symptoms after one week of wearing single vision soft spherical contact lenses.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.2  (6.8) 10.8  (5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
Comments In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Mixed Models Analysis
Comments Least-squares adjusted means were obtained and compared.
5.Secondary Outcome
Title Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
Hide Description CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
Arm/Group Title Test Arm: Multifocal Soft Contact Lenses Control Arm: Single Vision Spherical Contact Lenses
Hide Arm/Group Description:
Symptoms after one week of wearing multifocal soft spherical contact lenses.
Symptoms after one week of wearing single vision soft spherical contact lenses.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.7  (6.4) 11.0  (4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
Comments In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments Least-squares adjusted means were obtained and compared.
6.Secondary Outcome
Title Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Hide Description Measured via Modified Thorington
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
Arm/Group Title Test Arm: Multifocal Soft Contact Lenses Control Arm: Single Vision Spherical Contact Lenses
Hide Arm/Group Description:
Near Phoria while wearing multifocal soft spherical contact lenses.
Near Phoria while wearing single vision soft spherical contact lenses.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Prism Diopters of Exophoria
2.3  (3.8) 2.0  (4.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Arm: Multifocal Soft Contact Lenses, Control Arm: Single Vision Spherical Contact Lenses
Comments In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Mixed Models Analysis
Comments Least-squares adjusted means were obtained and compared.
7.Post-Hoc Outcome
Title Participants Stratified by Subjects' Near Phoria With Single Vision Lenses
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Phoria at near as measured through the single vision spherical contact lenses
Arm/Group Title Phoria in Single Vision Spherical Contact Lenses
Hide Arm/Group Description:
Phoria at near as measured through the single vision spherical contact lenses
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Esophoria at Near
5
  22.7%
Exophoria/ Orthophoria at Near
17
  77.3%
8.Post-Hoc Outcome
Title Phoria and Lens Preference
Hide Description Subjects' phoria at near with single vision lenses was classified as esophoric or exophoric. Lens preference was compared (multifocal vs single vision lenses) between the subjects who were esophoric at near vs the subjects who were exophoric/orthophoric at near.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Of the 22 completed subjects, 5 had an esophoria at near. 17 were exophoric or orthophoric at near.
Arm/Group Title Esophoric at Near Exophoric or Orthophoria at Near
Hide Arm/Group Description:
Subjects who are esophoric at near with single vision contact lenses
Subjects who were exophoric or orthophoric at near in single vision contact lenses
Overall Number of Participants Analyzed 5 17
Measure Type: Count of Participants
Unit of Measure: Participants
Preferred Multifocal Contact Lenses
5
 100.0%
2
  11.8%
Preferred Single Vision Contact Lenses
0
   0.0%
15
  88.2%
Time Frame Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multifocal Contact Lenses Single Vision Contact Lenses
Hide Arm/Group Description Adverse Events while wearing Multifocal Contact Lenses Adverse Events while wearing Single Vision Contact Lenses
All-Cause Mortality
Multifocal Contact Lenses Single Vision Contact Lenses
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/23 (0.00%)    
Hide Serious Adverse Events
Multifocal Contact Lenses Single Vision Contact Lenses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multifocal Contact Lenses Single Vision Contact Lenses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      1/23 (4.35%)    
Eye disorders     
Conjunctival Hyperemia * [1]  0/22 (0.00%)  0 1/23 (4.35%)  2
Subcojnunctival Hemorrhage   1/22 (4.55%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cold Like Symptoms *  1/22 (4.55%)  1 0/23 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Occurred after lens removal
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Danielle Iacono, OD
Organization: SUNY College of Optometry Clinical Vision Research Center
Phone: 212-938-5936
EMail: diacono@sunyopt.edu
Publications:
Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
Rueff, Erin. Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar Symptoms. (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015.
Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.
Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.
Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.
Layout table for additonal information
Responsible Party: Danielle Iacono, State University of New York College of Optometry
ClinicalTrials.gov Identifier: NCT02921087    
Other Study ID Numbers: 923606
First Submitted: September 29, 2016
First Posted: September 30, 2016
Results First Submitted: July 15, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019