AsthenopiaNCT03585790
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
A study testing Contact lens with Multifocal Optics and Contact lens with Single Vision Optics in people with Asthenopia and Myopia, run by Pete Kollbaum, OD, PhD at 1 site in United States.
Trial summary
Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthenopia, Myopia
- What is being tested?
- Contact lens with Multifocal Optics and Contact lens with Single Vision Optics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 2 Nov 2018
- 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
- Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
- Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
- Mobile digital device with active data and text plan, able to receive email and text messages
- Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
- Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
- 18-35 years of age
Show all 10Show fewer
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Vertex corrected refractive cylinder must be -0.75 or less.
- Visual acuity best correctable to 20/25 or better for each eye
- The subject must read and sign the Informed Consent form.
Who cannot join
- A habitual wearer of any of the test lenses
- Any active conditions that may prevent soft contact lens wear.
- Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
- Any doctor diagnosed, self-reported accommodative or binocular vision issues
- History of issues of eye alignment or binocularity by self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Clinical Optics Research Lab
Bloomington, Indiana, 47405
About this study
Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.
- Conditions
- Asthenopia, Myopia
- Being tested
- Contact lens with Multifocal Optics, Contact lens with Single Vision Optics
- Keywords
- Eye Fatigue
- Medical subject headings
- Asthenopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lens with Multifocal OpticsDevice
This contact lens has optics to aid the accommodative and convergence systems
Contact lens with Single Vision OpticsDevice
This contact lens has standard single vision optics
| Study group | Role | What they receive |
|---|---|---|
| Multifocal Optics first, then Single Vision Optics | Other | First Intervention (1 week) Second Intervention (1 week) Receives: Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics |
| Single Vision Optics first, then Multifocal Optics | Other | First Intervention (1 week) Second Intervention (1 week) Receives: Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Reported Eye Fatigue
Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above.
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 posted13 Jul 2018
- Study start13 Sep 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pete Kollbaum, OD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Pete Kollbaum, OD, PhD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585790
- Sponsor's protocol ID
- Kollbaum001
- Status last verified
- Dec 2019
- First submitted
- 26 Apr 2018
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT03585790
- Acronym / sponsor ID
- Kollbaum001
- Conditions
- Asthenopia, Myopia
- Keywords
- Eye Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pete Kollbaum, OD, PhDUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Posted 7 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal Optics first, then Single Vision Optics | Other | Device: Contact lens with Multifocal Optics, Device: Contact lens with Single Vision OpticsFirst Intervention (1 week) Second Intervention (1 week) |
| Single Vision Optics first, then Multifocal Optics | Other | Device: Contact lens with Multifocal Optics, Device: Contact lens with Single Vision OpticsFirst Intervention (1 week) Second Intervention (1 week) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
- Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
- Mobile digital device with active data and text plan, able to receive email and text messages
- Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
- Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
Key exclusion criteria (5 listed)
- A habitual wearer of any of the test lenses
- Any active conditions that may prevent soft contact lens wear.
- Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
- Any doctor diagnosed, self-reported accommodative or binocular vision issues
- History of issues of eye alignment or binocularity by self-report
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 |
|---|---|---|
| Contact lens with Multifocal OpticsThis contact lens has optics to aid the accommodative and convergence systems | Device | Multifocal Optics first, then Single Vision Optics, Single Vision Optics first, then Multifocal Optics |
| Contact lens with Single Vision OpticsThis contact lens has standard single vision optics | Device | Multifocal Optics first, then Single Vision Optics, Single Vision Optics first, then Multifocal Optics |
Primary outcome
Subject Reported Eye Fatigue
Time frame: 1 week
Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact lens with Multifocal Optics and Contact lens with Single Vision Optics in people with Asthenopia and Myopia, run by Pete Kollbaum, OD, PhD 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 5 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 7 Jan 2020. 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 7 Jan 2020). 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?
Subject Reported Eye Fatigue (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020.