Contact LensNCT04844281

Wear Experience With Daily Toric Contact Lenses Over a Long Day

A study testing Precision1® Daily Disposable Toric Contact Lens in people with Contact Lens and Astigmatism of Both Eyes, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Contact Lens, Astigmatism of Both Eyes
What is being tested?: Precision1® Daily Disposable Toric 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: 11 May 2021to 24 Aug 2021
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
Distance visual acuity of 20/25 or better with current lenses.
Recent eye exam in the last year.
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.
Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.

Who cannot join

Current ocular inflammation or infection as assessed by the study investigator.
Currently pregnant, lactating, or planning to become pregnant during the course of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days

This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.

Conditions: Contact Lens, Astigmatism of Both Eyes
Being tested: Precision1® Daily Disposable Toric Contact Lens
Keywords: Toric Contact Lens, Daily Contact Lens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Precision1® Daily Disposable Toric Contact LensDevice
Soft, toric contact lens used to correct distance vision and astigmatism.

Study groups in NCT04844281
Study group	Role	What they receive
Daily Disposable Toric Contact Lens	Experimental	All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Receives: Device: Precision1® Daily Disposable Toric Contact Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
1 describes poor experience, and 10 describes excellent experience.
Measured: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
1 describes poor experience, and 10 describes excellent experience.
Measured: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202124 Aug 2021

First posted14 Apr 2021
Study start11 May 2021
Primary completion24 Aug 2021
Study completion24 Aug 2021

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
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04844281
Sponsor's protocol ID: 2020H0559
Status last verified: Nov 2023
First submitted: 9 Apr 2021
Last updated: 29 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
Not yet recruiting
Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
Myopia
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)

All Contact Lens trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days
ClinicalTrials.gov ID: NCT04844281
Acronym / sponsor ID: 2020H0559
Conditions: Contact Lens, Astigmatism of Both Eyes
Keywords: Toric Contact Lens, Daily 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: 11 May 2021 (actual)
Primary completion: 24 Aug 2021 (actual)
Study completion: 24 Aug 2021 (actual)
First posted: 14 Apr 2021 (actual)
Results: Posted 29 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daily Disposable Toric Contact Lens	Experimental	Device: Precision1® Daily Disposable Toric Contact LensAll subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
Distance visual acuity of 20/25 or better with current lenses.
Recent eye exam in the last year.
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.

Key exclusion criteria (2 listed)

Current ocular inflammation or infection as assessed by the study investigator.
Currently pregnant, lactating, or planning to become pregnant during the course of the study.

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
Precision1® Daily Disposable Toric Contact LensSoft, toric contact lens used to correct distance vision and astigmatism.	Device	Daily Disposable Toric Contact Lens

Primary outcome

Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
Time frame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
1 describes poor experience, and 10 describes excellent experience.
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
Time frame: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days
1 describes poor experience, and 10 describes excellent experience.

Results and safety

Results posted to the registry on 29 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daily Disposable Toric Contact Lens	30	30

Primary outcome: Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)

Time frame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Daily Disposable Toric Contact Lens n = 30
Value	9 (7 to 10)

Primary outcome: Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)

Time frame: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Daily Disposable Toric Contact Lens n = 30
Value	8.4 (7 to 9)

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daily Disposable Toric Contact Lens	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Contact Lens

Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
Not yet recruiting
Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
Myopia
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)

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 Precision1® Daily Disposable Toric Contact Lens in people with Contact Lens and Astigmatism of Both Eyes, 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 29 Nov 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 29 Nov 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?

Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) (time frame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.). 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?

On the ClinicalTrials.gov record for NCT04844281.

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 29 Nov 2023.