MyopiaNCT05028790
Evaluating Contact Lens Optics
A study testing Single vision contact lens and Multifocal contact lens in people with Myopia, run by David A Berntsen, OD PhD at 1 site in United States.
Trial summary
This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Myopia
- What is being tested?
- Single vision contact lens and Multifocal contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2022to 13 Dec 2022
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to read and understand the informed consent document
- 18 to 39 years of age (inclusive)
- Best corrected visual acuity of 20/25 or better in the right eye
- Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)
Who cannot join
- Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
- History of ocular trauma or surgery causing abnormal or distorted vision
- Current Rigid Gas Permeable (RGP) contact lens wearers
- Unwilling to have contact lens fit photographed
- Pregnant and/or lactating females, by self-report
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens
- Conditions
- Myopia
- Being tested
- Single vision contact lens, Multifocal contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single vision contact lensDevice
Also called comfilcon A
Participants will wear a single vision soft contact lens during the study visit
Multifocal contact lensDevice
Also called comfilcon A
Participants will wear a multifocal soft contact lens during the study visit
| Study group | Role | What they receive |
|---|---|---|
| Single vision soft contact lens first, then multifocal soft contact lens | Experimental | Participants wore the single vision soft contact lens first, then a multifocal soft contact lens Receives: Device: Single vision contact lens; Device: Multifocal contact lens |
| Multifocal soft contact lens first, then single vision soft contact lens | Experimental | Participants wore the multifocal soft contact lens first, then the single vision soft contact lens Receives: Device: Single vision contact lens; Device: Multifocal contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Performance
Low contrast visual acuity was measured for each participant while wearing each of the two lenses
Measured: Through completion of study visit, an average of 2.5 hours
Secondary outcomes (5)
Spherical Equivalent Refractive Error On-axis
Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.
Measured: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina
Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Measured: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina
Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Measured: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina
Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Measured: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina
Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Measured: Through completion of study visit, an average of 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start27 Feb 2022
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
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 MyopiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- David A Berntsen, OD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David A Berntsen, OD PhD, University of Houston
- Investigators
- David A Berntsen, OD, PhD, Principal investigator, University of Houston College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028790
- Sponsor's protocol ID
- STUDY00002545
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2021
- Last updated
- 6 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Contact Lens Optics
- ClinicalTrials.gov ID
- NCT05028790
- Acronym / sponsor ID
- STUDY00002545
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- David A Berntsen, OD PhDUniversity, hospital or other
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 6 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single vision soft contact lens first, then multifocal soft contact lens | Experimental | Device: Single vision contact lens, Device: Multifocal contact lensParticipants wore the single vision soft contact lens first, then a multifocal soft contact lens |
| Multifocal soft contact lens first, then single vision soft contact lens | Experimental | Device: Single vision contact lens, Device: Multifocal contact lensParticipants wore the multifocal soft contact lens first, then the single vision soft contact lens |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to read and understand the informed consent document
- 18 to 39 years of age (inclusive)
- Best corrected visual acuity of 20/25 or better in the right eye
- Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)
Key exclusion criteria (5 listed)
- Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
- History of ocular trauma or surgery causing abnormal or distorted vision
- Current Rigid Gas Permeable (RGP) contact lens wearers
- Unwilling to have contact lens fit photographed
- Pregnant and/or lactating females, 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 |
|---|---|---|
| Single vision contact lensAlso: comfilcon AParticipants will wear a single vision soft contact lens during the study visit | Device | Multifocal soft contact lens first, then single vision soft contact lens, Single vision soft contact lens first, then multifocal soft contact lens |
| Multifocal contact lensAlso: comfilcon AParticipants will wear a multifocal soft contact lens during the study visit | Device | Multifocal soft contact lens first, then single vision soft contact lens, Single vision soft contact lens first, then multifocal soft contact lens |
Primary outcome
Visual Performance
Time frame: Through completion of study visit, an average of 2.5 hours
Low contrast visual acuity was measured for each participant while wearing each of the two lenses
5 secondary outcomes
Spherical Equivalent Refractive Error On-axis
Time frame: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina
Time frame: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina
Time frame: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina
Time frame: Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina
Time frame: Through completion of study visit, an average of 2.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David A Berntsen, OD, PhD principal investigator
University of Houston College of 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 Single vision contact lens and Multifocal contact lens in people with Myopia, run by David A Berntsen, 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 4 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 6 Feb 2024. 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 6 Feb 2024). 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?
Visual Performance (time frame: Through completion of study visit, an average of 2.5 hours). 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 6 Feb 2024.