AsthenopiaNCT02921087
Connecting Contact Lenses and Digital Technology
A study testing Test Daily Disposable Soft Contact Lenses in people with Asthenopia and Contact Lenses, run by State University of New York College of Optometry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthenopia, Contact Lenses, Ocular Accommodation
- What is being tested?
- Test Daily Disposable Soft Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 years of age
- Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
- Current single-vision soft contact lens wearer
- Monocular acuity of 20/25 or better in each eye (Snellen)
- Self-reported minimum of 6 hours a day on digital devices
- Self-reported complaint of eyestrain on digital devices
Show all 10Show fewer
- No ocular pathology and/or history of eye surgery
- No history of strabismus or strabismus surgery
- No gas permeable lens wear for at least 3 months
- Subjects may not be optometrists, opticians or optometry students
Who cannot join
- Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
- Negative Relative Accommodation (NRA) less than +1.50 D
- Exophoria at near > 6 prism diopters10
- Vertical phoria > 1 prism diopter
- Presence of tropia
- Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)
- Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Test Daily Disposable Soft Contact Lenses, Control Daily Disposable Soft Contact Lenses
- Medical subject headings
- Asthenopia, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Daily Disposable Soft Contact LensesDevice
Worn daily for 7 +/- 2 days
Control Daily Disposable Soft Contact LensesDevice
Worn daily for 7 +/- 2 days
| Study group | Role | What they receive |
|---|---|---|
| Test followed by control | Other | 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. Receives: Device: Test Daily Disposable Soft Contact Lenses; Device: Control Daily Disposable Soft Contact Lenses |
| Control followed by test | Other | 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. Receives: Device: Test Daily Disposable Soft Contact Lenses; Device: Control Daily Disposable Soft Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Symptom Improvement
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).
Measured: Baseline and after 1 week of wearing each lens.
Secondary outcomes (5)
Lens Preference
Based on two alternative forced choice method
Measured: 2 weeks
Lag of Accommodation in Study Lenses
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.
Measured: 1 week
Convergence Insufficiency Symptom Survey (CISS)
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.
Measured: 1 week
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
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).
Measured: 1 week
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Measured via Modified Thorington
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJan 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AsthenopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Responsible party
- Principal investigator, Danielle Iacono, State University of New York College of Optometry
- Investigators
- Danielle Iacono, OD, Principal investigator, SUNY Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921087
- Sponsor's protocol ID
- 923606
- Status last verified
- Aug 2019
- First submitted
- 29 Sep 2016
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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. doi: 10.1111/j.1475-1313.2004.00202.x.
PubMed 15315652Chalmers 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.
PubMed 22960615Jaschinski 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.
PubMed 11913842Richdale 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.
PubMed 16699438Fedtke 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.
PubMed 26228543Efron, 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. doi: 10.1097/OPX.0b013e31812f7546.
PubMed 17700327
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Contact Lenses and Digital Technology
- ClinicalTrials.gov ID
- NCT02921087
- Acronym / sponsor ID
- 923606
- Conditions
- Asthenopia, Contact Lenses, Ocular Accommodation, Convergence, Excess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Study start
- Jan 2017
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test followed by control | Other | Device: Test Daily Disposable Soft Contact Lenses, Device: Control Daily Disposable Soft Contact LensesSubjects 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. |
| Control followed by test | Other | Device: Test Daily Disposable Soft Contact Lenses, Device: Control Daily Disposable Soft Contact LensesSubjects 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18 to 35 years of age
- Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
- Current single-vision soft contact lens wearer
- Monocular acuity of 20/25 or better in each eye (Snellen)
- Self-reported minimum of 6 hours a day on digital devices
Key exclusion criteria (7 listed)
- Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
- Negative Relative Accommodation (NRA) less than +1.50 D
- Exophoria at near > 6 prism diopters10
- Vertical phoria > 1 prism diopter
- Presence of tropia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Daily Disposable Soft Contact LensesWorn daily for 7 +/- 2 days | Device | Control followed by test, Test followed by control |
| Control Daily Disposable Soft Contact LensesWorn daily for 7 +/- 2 days | Device | Control followed by test, Test followed by control |
Primary outcome
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).
5 secondary outcomes
Lens Preference
Time frame: 2 weeks
Lag of Accommodation in Study Lenses
Time frame: 1 week
Convergence Insufficiency Symptom Survey (CISS)
Time frame: 1 week
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
Time frame: 1 week
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundEmber, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
- BackgroundRueff, Erin. Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar Symptoms. (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015.
- BackgroundCooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.
- Background: PubMed 15315652Rouse 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.
- Background: PubMed 22960615Chalmers 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.
- Background: PubMed 11913842Jaschinski 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.
- Background: PubMed 16699438Richdale 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.
- Background: PubMed 26228543Fedtke 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.
- BackgroundEfron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.
- BackgroundMorgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.
- Background: PubMed 17700327Hayes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Iacono, OD principal investigator
SUNY Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Daily Disposable Soft Contact Lenses in people with Asthenopia and Contact Lenses, run by State University of New York College of Optometry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Symptom Improvement (time frame: Baseline and after 1 week of wearing each lens.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921087, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.