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
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Study Type | Interventional |
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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 |
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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).
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Arm/Group Title | Test Followed by Control | Control Followed by Test | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 12 participants | 11 participants | 23 participants | |
Female |
9 75.0%
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10 90.9%
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19 82.6%
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Male |
3 25.0%
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1 9.1%
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4 17.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 11 participants | 23 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
12 100.0%
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11 100.0%
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23 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 11 participants | 23 participants | |
American Indian or Alaska Native |
1 8.3%
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0 0.0%
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1 4.3%
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Asian |
2 16.7%
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3 27.3%
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5 21.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 8.3%
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2 18.2%
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3 13.0%
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White |
7 58.3%
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5 45.5%
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12 52.2%
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More than one race |
1 8.3%
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1 9.1%
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2 8.7%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 12 participants | 11 participants | 23 participants |
12 | 11 | 23 |
Name/Title: | Danielle Iacono, OD |
Organization: | SUNY College of Optometry Clinical Vision Research Center |
Phone: | 212-938-5936 |
EMail: | diacono@sunyopt.edu |
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 |