PresbyopiaNCT06053463
Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
A study testing Daily disposable multifocal soft contact lens in people with Presbyopia, run by Jennifer Fogt at 2 sites in United States.
Trial summary
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear. Read more about this study
- Who is it for?
- Ages 38 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Daily disposable multifocal soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2023to 23 May 2024
- 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 38 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Any gender.
- Any racial or ethnic origin.
- At least 38 years of age or older.
- Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
- Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
Show all 9Show fewer
- Spectacle sphere power range between +6.00 to -10.00.
- Previously dropped out of contact lens wear due to vision or vision and discomfort.
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI
Who cannot join
- Current or active ocular inflammation or infection as determined by the Investigator.
- Astigmatism ≥ 1.00 D in either eye.
- History of previous eye surgery.
- Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
- Demonstration or history of corneal ectasia or keratoconus.
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University College of Optometry
Columbus, Ohio, 43210
ProCare Vision Center
Granville, Ohio, 43023
About this study
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
Read the detailed description
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.
- Conditions
- Presbyopia
- Being tested
- Daily disposable multifocal soft contact lens
- Keywords
- contact lenses, Multifocal contact lenses
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily disposable multifocal soft contact lensDevice
Daily disposable multifocal soft contact lens that will be worn for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Lens wear experience | Experimental | Subject will wear contact lenses for about a month during the day. Receives: Device: Daily disposable multifocal soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (> 50).
Measured: 1 month
Quality of Life Survey
Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start6 Oct 2023
- Primary completion23 May 2024
- Study completion23 May 2024
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 PresbyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Fogt
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Jennifer Fogt, Ohio State University
- Investigators
- Jennifer Fogt, OD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053463
- Sponsor's protocol ID
- 2023H0245
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2023
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT06053463
- Acronym / sponsor ID
- 2023H0245
- Conditions
- Presbyopia
- Keywords
- contact lenses, Multifocal contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Jennifer FogtUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
Detailed description
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lens wear experience | Experimental | Device: Daily disposable multifocal soft contact lensSubject will wear contact lenses for about a month during the day. |
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to give informed consent.
- Any gender.
- Any racial or ethnic origin.
- At least 38 years of age or older.
- Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
Key exclusion criteria (6 listed)
- Current or active ocular inflammation or infection as determined by the Investigator.
- Astigmatism ≥ 1.00 D in either eye.
- History of previous eye surgery.
- Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
- Demonstration or history of corneal ectasia or keratoconus.
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 |
|---|---|---|
| Daily disposable multifocal soft contact lensDaily disposable multifocal soft contact lens that will be worn for 1 month. | Device | Lens wear experience |
Primary outcome
Visual Analog Scale
Time frame: 1 month
Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (> 50).
Quality of Life Survey
Time frame: 1 month
Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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.
Jennifer Fogt, OD, MS principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily disposable multifocal soft contact lens in people with Presbyopia, run by Jennifer Fogt at 2 sites 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 9 inclusion and 6 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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 27 Nov 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 Analog Scale (time frame: 1 month). The study lists 2 primary outcomes in all. 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 27 Nov 2024.