Visual AcuityNCT05433571

Evaluation of Rotation With a Multifocal Toric Contact Lens

A study testing Test Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 sites 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

The study is a bilateral, single-masked, single-visit, non-dispensing 2x2 crossover study to confirm a finalized design of a prototype contact lens. There will be eight study lens types, however, each subject will only be randomized to receive two study lens types. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: Test Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 5 sitesUnited States
Study dates: 28 Jun 2022to 22 Jul 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 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be at least 40 and not more than 70 years of age at the time of screening.
Own a wearable pair of spectacles with distance vision correction.
Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past four weeks).

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Have distance spherical equivalent refraction in the range of either -1.00 D to -6.00 D or +1.00 to +6.00 D in each eye.
Have distance cylinder refraction in the range of -0.75 to - 2.50 D in each eye, with the axis being in the range of either 90 ± 30° or 180 ± 30°.
Have best corrected distance visual acuity of 20/25 or better in each eye.

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Be currently pregnant or lactating.
Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications.
Currently use ocular medication with the exception of rewetting drops.

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Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, or sodium fluorescein.
Have had any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
Have a history of amblyopia or strabismus.
Have a history of herpetic keratitis.
Have a history of irregular cornea.
Have a history of pathological dry eye.
Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
Have any current ocular infection or inflammation.
Have any other ocular abnormality that may interfere with contact lens wear

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Stam & Associates Eye Care
Jacksonville, Florida, 32256
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Center for Ophthalmic and Vision Research/Eye Associates of New York
Manhattan, New York, 10022
Tyler Eye Associates
Tyler, Texas, 75703

Other trials in United States

About this study

Conditions: Visual Acuity
Being tested: Test Lens

What participants receive

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

Test LensDevice
Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter

Study groups in NCT05433571
Study group	Role	What they receive
Myopes - Against the Rule Sequence 1	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens
Myopes - Against the Rule Sequence 2	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens
Myopes - With the Rule Sequence 1	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens
Myopes - With the Rule Sequence 2	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens
Hyperopes - Against the Rule Sequence 1	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens
Hyperopes - Against the Rule Sequence 2	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at time bilaterally over 2 wear periods. Receives: Device: Test Lens
Hyperope - With the Rule Sequence 1	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens
Hyperope - With the Rule Sequence 2	Experimental	Eligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods. Receives: Device: Test Lens

What is being measured

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

Proportion of Eyes With Absolute Rotation ≤ 10 Degrees
Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Measured: 15-minutes post lens insertion

Timeline

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

28 Jun 202222 Jul 2022

First posted27 Jun 2022
Study start28 Jun 2022
Primary completion22 Jul 2022
Study completion22 Jul 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 Visual AcuityStudies 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05433571
Sponsor's protocol ID: CR-6491
Status last verified: Jun 2023
First submitted: 21 Jun 2022
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Rotation With a Multifocal Toric Contact Lens
ClinicalTrials.gov ID: NCT05433571
Acronym / sponsor ID: CR-6491
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jun 2022 (actual)
Primary completion: 22 Jul 2022 (actual)
Study completion: 22 Jul 2022 (actual)
First posted: 27 Jun 2022 (actual)
Results: Posted 27 Jul 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
Myopes - Against the Rule Sequence 1	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.
Myopes - Against the Rule Sequence 2	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Myope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.
Myopes - With the Rule Sequence 1	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.
Myopes - With the Rule Sequence 2	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Myope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.
Hyperopes - Against the Rule Sequence 1	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.
Hyperopes - Against the Rule Sequence 2	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, against-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at time bilaterally over 2 wear periods.
Hyperope - With the Rule Sequence 1	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (LOW/HIGH DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.
Hyperope - With the Rule Sequence 2	Experimental	Device: Test LensEligible subjects that are habitual contact lens wearers will be randomized to the Hyperope, with-the-rule-astigmatism, (HIGH/LOW DC) sequence and wear two different study lens designs one at a time bilaterally over 2 wear periods.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be at least 40 and not more than 70 years of age at the time of screening.
Own a wearable pair of spectacles with distance vision correction.

Key exclusion criteria (18 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Be currently pregnant or lactating.
Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications.

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
Test LensMultifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter	Device	Hyperope - With the Rule Sequence 1, Hyperope - With the Rule Sequence 2, Hyperopes - Against the Rule Sequence 1, Hyperopes - Against the Rule Sequence 2, Myopes - Against the Rule Sequence 1, Myopes - Against the Rule Sequence 2, Myopes - With the Rule Sequence 1, Myopes - With the Rule Sequence 2

Primary outcome

Proportion of Eyes With Absolute Rotation ≤ 10 Degrees
Time frame: 15-minutes post lens insertion
Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.

Results and safety

Results posted to the registry on 27 Jul 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
Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)	53	53
Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)	49	49

Primary outcome: Proportion of Eyes With Absolute Rotation ≤ 10 Degrees

Time frame: 15-minutes post lens insertion. Number. Unit: Proportion

Measure	Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low DC) n = 102	Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC) n = 102
Value	0.9167	0.8873

Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low DC): Mean Population Estimate: 0.917 (95% CI 0.878 to 0.955), Bootstrapping Methods
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC): Mean Population Estimate: 0.887 (95% CI 0.845 to 0.930), Bootstrapping Methods

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.

Adverse events

Time frame: Throughout the duration of the study. Approximately 1-Day per Subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low C)	0 of 102 (0%)	0 of 102 (0%)	0 of 102
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC)	0 of 102 (0%)	0 of 102 (0%)	0 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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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.

Johnson & Johnson Vision Care, Inc. Clinical Trial study director

Johnson & Johnson Vision Care, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 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 18 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 Jul 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?

Proportion of Eyes With Absolute Rotation ≤ 10 Degrees (time frame: 15-minutes post lens insertion). 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 NCT05433571.

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 Jul 2023.