Connecting Contact Lenses and Digital Technology

• 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: State University of New York College of Optometry
• 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

Participant Flow

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
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).

Baseline Characteristics

Arm/Group Title		Test Followed by Control	Control Followed by Test	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Subjective Symptom Improvement
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.

Outcome Measure Data

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
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)

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
Description	Based on two alternative forced choice method
Time Frame	2 weeks

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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

Outcome Measure Data

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
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)

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)
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

Outcome Measure Data

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
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)

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
Description	Measured via Modified Thorington
Time Frame	1 week

Outcome Measure Data

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
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)

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
Description	[Not Specified]
Time Frame	1 week

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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%

Adverse Events

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
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%)
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%)
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

Limitations and 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.

Results Point of Contact

• 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.

Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R, Wensveen J; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004 Sep;24(5):384-90.

Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis Sci. 2012 Oct;89(10):1435-42.

Jaschinski W. The proximity-fixation-disparity curve and the preferred viewing distance at a visual display as an indicator of near vision fatigue. Optom Vis Sci. 2002 Mar;79(3):158-69.

Richdale K, Mitchell GL, Zadnik K. Comparison of multifocal and monovision soft contact lens corrections in patients with low-astigmatic presbyopia. Optom Vis Sci. 2006 May;83(5):266-73.

Fedtke C, Bakaraju RC, Ehrmann K, Chung J, Thomas V, Holden BA. Visual performance of single vision and multifocal contact lenses in non-presbyopic myopic eyes. Cont Lens Anterior Eye. 2016 Feb;39(1):38-46. doi: 10.1016/j.clae.2015.07.005. Epub 2015 Jul 27.

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.

Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44.

• 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