MyopiaNCT05308069
Contact Lens Optics and Visual Performance
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 visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 -8.00D 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
- 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 visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer
- 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
Subjects will wear a single vision soft contact lens only during the study visit
Multifocal contact lensDevice
Also called comfilcon A
Subjects will wear a multifocal soft contact lens only during the study visit
| Study group | Role | What they receive |
|---|---|---|
| Single vision contact lens | Other | Subjects will wear a single vision soft contact lens during the study visit Receives: Device: Single vision contact lens |
| Multifocal contact lens | Other | Subjects will wear a multifocal soft contact lens during the study visit Receives: 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 performance will be measured at different pupil sizes for each subject while wearing each of the two lenses
Measured: Through completion of study visit, an average of 3 hours
Secondary outcomes (1)
Refractive error
Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses
Measured: Through completion of study visit, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start13 Jun 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 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
- NCT05308069
- Sponsor's protocol ID
- STUDY00003513
- Status last verified
- Aug 2022
- First submitted
- 24 Mar 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lens Optics and Visual Performance
- ClinicalTrials.gov ID
- NCT05308069
- Acronym / sponsor ID
- STUDY00003513
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- David A Berntsen, OD PhDUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
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 visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single vision contact lens | Other | Device: Single vision contact lensSubjects will wear a single vision soft contact lens during the study visit |
| Multifocal contact lens | Other | Device: Multifocal contact lensSubjects will wear a multifocal soft contact lens during the study visit |
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 -8.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)
Key exclusion criteria (4 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
- 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 ASubjects will wear a single vision soft contact lens only during the study visit | Device | Single vision contact lens |
| Multifocal contact lensAlso: comfilcon ASubjects will wear a multifocal soft contact lens only during the study visit | Device | Multifocal contact lens |
Primary outcome
Visual performance
Time frame: Through completion of study visit, an average of 3 hours
Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses
1 secondary outcome
Refractive error
Time frame: Through completion of study visit, an average of 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- 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 4 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 9 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 3 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 9 Aug 2022.