Contact LensNCT04296877
Evaluation of Wear Experience With a Daily Disposable Contact Lens
A study testing Daily Disposable Contact Lens in people with Contact Lens, run by Ohio State University at 1 site in United States.
Trial summary
To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens
- What is being tested?
- Daily Disposable Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 1 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be current Acuvue® Oasys® spherical contact lens wearers.
- Distance visual acuity of 20/25 or better with current contact lenses.
- 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).
- Ability to give informed consent.
- Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.
- Either gender.
- Any racial or ethnic origin.
Who cannot join
- No current ocular inflammation or infection.
- Not currently pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
Official title: Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers
To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.
Read the detailed description
This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.
- Conditions
- Contact Lens
- Being tested
- Daily Disposable Contact Lens
- Keywords
- Daily Disposable Contact Lens, Soft Contact Lens, Spherical Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Disposable Contact LensDevice
Soft, daily disposable spherical contact lens used to correct distance vision.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for ~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days. Receives: Device: Daily Disposable Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey
Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start10 Mar 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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 Contact LensStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Model description
- This is a single arm, non-comparative study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Jennifer Fogt, Ohio State University
- Investigators
- Jennifer Fogt, OD, MS, Principal investigator, The Ohio State University College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296877
- Sponsor's protocol ID
- 2020H0019
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2020
- Last updated
- 7 Mar 2023
- 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers
- ClinicalTrials.gov ID
- NCT04296877
- Acronym / sponsor ID
- 2020H0019
- Conditions
- Contact Lens
- Keywords
- Daily Disposable Contact Lens, Soft Contact Lens, Spherical Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.
Detailed description
This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, non-comparative study.
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Device: Daily Disposable Contact LensAll subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for ~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be current Acuvue® Oasys® spherical contact lens wearers.
- Distance visual acuity of 20/25 or better with current contact lenses.
- 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).
- Ability to give informed consent.
- Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits.
Key exclusion criteria (2 listed)
- No current ocular inflammation or infection.
- Not currently pregnant or lactating.
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 Contact LensSoft, daily disposable spherical contact lens used to correct distance vision. | Device | All study participants |
Primary outcome
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey
Time frame: 2 weeks
Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- 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.
Jennifer Fogt, OD, MS principal investigator
The Ohio State University 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 Daily Disposable Contact Lens in people with Contact Lens, run by Ohio State University 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 7 inclusion and 2 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 Mar 2023. 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 Mar 2023). 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?
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey (time frame: 2 weeks). 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 Mar 2023.