Connecting Contact Lenses and Digital Technology

NCT ID: NCT02921087

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-11-20

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.

Conditions

Asthenopia; Contact Lenses; Ocular Accommodation; Convergence, Excess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Test Daily Disposable Soft Contact Lenses

Intervention Type: DEVICE

Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses

Intervention Type: DEVICE

Worn daily for 7 +/- 2 days

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.

Group Type: OTHER

Test Daily Disposable Soft Contact Lenses

Intervention Type: DEVICE

Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses

Intervention Type: DEVICE

Worn daily for 7 +/- 2 days

Interventions

Test Daily Disposable Soft Contact Lenses

Worn daily for 7 +/- 2 days

Intervention Type: DEVICE

Control Daily Disposable Soft Contact Lenses

Worn daily for 7 +/- 2 days

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: collaborator

State University of New York College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Danielle Iacono

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle Iacono, OD

Role: PRINCIPAL_INVESTIGATOR

SUNY Optometry

Locations

SUNY College of Optometry

New York, New York, United States

Countries

United States

References

Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.

Reference Type: BACKGROUND

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. doi: 10.1111/j.1475-1313.2004.00202.x.

Reference Type: BACKGROUND

PMID: 15315652 (View on PubMed)

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. doi: 10.1097/OPX.0b013e318269c90d.

Reference Type: BACKGROUND

PMID: 22960615 (View on PubMed)

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. doi: 10.1097/00006324-200203000-00010.

Reference Type: BACKGROUND

PMID: 11913842 (View on PubMed)

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. doi: 10.1097/01.opx.0000216098.62165.34.

Reference Type: BACKGROUND

PMID: 16699438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26228543 (View on PubMed)

Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.

Reference Type: BACKGROUND

Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.

Reference Type: BACKGROUND

Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.

Reference Type: BACKGROUND

PMID: 17700327 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

923606

Identifier Type: -

Identifier Source: org_study_id