Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Connecting Contact Lenses and Digital Technology

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: 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

Tracking Information
First Submitted Date  ICMJE September 29, 2016
First Posted Date  ICMJE September 30, 2016
Results First Submitted Date  ICMJE July 15, 2019
Results First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Study Start Date  ICMJE January 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
Subjective Symptom Improvement [ Time Frame: Baseline and after 1 week of wearing each lens. ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
Symptom Survey [ Time Frame: 1 week ]
Based on a 10 question VAS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • Lens Preference [ Time Frame: 2 weeks ]
    Based on two alternative forced choice method
  • Lag of Accommodation in Study Lenses [ Time Frame: 1 week ]
    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.
  • Convergence Insufficiency Symptom Survey (CISS) [ Time Frame: 1 week ]
    Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.
  • Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) [ Time Frame: 1 week ]
    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).
  • Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens [ Time Frame: 1 week ]
    Measured via Modified Thorington
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
Lens Preference [ Time Frame: 2 weeks ]
Based on two alternative forced choice method
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connecting Contact Lenses and Digital Technology
Official Title  ICMJE Connecting Contact Lenses and Digital Technology
Brief Summary This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.
Detailed Description This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthenopia
  • Contact Lenses
  • Ocular Accommodation
  • Convergence, Excess
Intervention  ICMJE
  • Device: Test Daily Disposable Soft Contact Lenses
    Worn daily for 7 +/- 2 days
  • Device: Control Daily Disposable Soft Contact Lenses
    Worn daily for 7 +/- 2 days
Study Arms  ICMJE
  • Test followed by control
    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.
    Interventions:
    • Device: Test Daily Disposable Soft Contact Lenses
    • Device: Control Daily Disposable Soft Contact Lenses
  • Control followed by test
    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.
    Interventions:
    • Device: Test Daily Disposable Soft Contact Lenses
    • Device: Control Daily Disposable Soft Contact Lenses
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
23
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
45
Actual Study Completion Date  ICMJE November 20, 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 to 35 years of age
  2. Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
  3. Current single-vision soft contact lens wearer
  4. Monocular acuity of 20/25 or better in each eye (Snellen)
  5. Self-reported minimum of 6 hours a day on digital devices
  6. Self-reported complaint of eyestrain on digital devices
  7. No ocular pathology and/or history of eye surgery
  8. No history of strabismus or strabismus surgery
  9. No gas permeable lens wear for at least 3 months
  10. Subjects may not be optometrists, opticians or optometry students

Exclusion Criteria:

  1. Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
  2. Negative Relative Accommodation (NRA) less than +1.50 D
  3. Exophoria at near > 6 prism diopters10
  4. Vertical phoria > 1 prism diopter
  5. Presence of tropia
  6. Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)
  7. Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02921087
Other Study ID Numbers  ICMJE 923606
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Danielle Iacono, State University of New York College of Optometry
Study Sponsor  ICMJE State University of New York College of Optometry
Collaborators  ICMJE Johnson & Johnson Vision Care, Inc.
Investigators  ICMJE
Principal Investigator: Danielle Iacono, OD SUNY Optometry
PRS Account State University of New York College of Optometry
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP