Visual AcuityNCT03713281

Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population

A study testing Toric Multifocal etafilcon A with PVP in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. 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

The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days. 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?: Toric Multifocal etafilcon A with PVP
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: 4 Oct 2018to 19 Feb 2019
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:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 40 and not more than 70 years of age at the time of screening.
The subject's distance spherical component of their refraction must be in the range of +1.25 D to +3.75 D in each eye.
The subject's refractive cylinder must be -1.00 to -1.50 D in each eye.

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The subject's ADD power must be in the range of +0.75 D to +1.50 D in each eye.
Subject's refractive cylinder axis must be within 90°±30° or 180°±30° in each eye.
The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Currently pregnant or lactating.
Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
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).
Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.

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Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
A history of amblyopia, strabismus or binocular vision abnormality.
Any current ocular infection or inflammation.
Any current ocular abnormality that may interfere with contact lens wear.
Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
Use of any ocular medication, with the exception of rewetting drops.
History of herpetic keratitis.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Any known hypersensitivity or allergic reaction to Eye-Cept® rewetting drop solution.

Trial locations and contacts

1 site in 1 country.

United States1 site

Total Eye Care PA
Memphis, Tennessee, 38119

Other trials in United States

About this study

The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.

Conditions: Visual Acuity
Being tested: Toric Multifocal etafilcon A with PVP

What participants receive

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

Toric Multifocal etafilcon A with PVPDevice
Investigational

Study groups in NCT03713281
Study group	Role	What they receive
Test Lens	Experimental	Subjects between the ages 40 to 70 years of age and who are adapted contact lens wearers with astigmatism in both eyes will be assigned to the same Test Lens according to the lens wear schedule. Receives: Device: Toric Multifocal etafilcon A with PVP

What is being measured

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

Distance Visual Acuity (logMAR)
High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Measured: 2-Week Follow-up
Near Visual Acuity (logMAR)
High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Measured: 2-Week Follow-up

Timeline

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

4 Oct 201819 Feb 2019

First posted19 Oct 2018
Study start4 Oct 2018
Primary completion19 Feb 2019
Study completion19 Feb 2019

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
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: NCT03713281
Sponsor's protocol ID: CR-6278
Status last verified: Apr 2025
First submitted: 18 Oct 2018
Last updated: 25 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population
ClinicalTrials.gov ID: NCT03713281
Acronym / sponsor ID: CR-6278
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 4 Oct 2018 (actual)
Primary completion: 19 Feb 2019 (actual)
Study completion: 19 Feb 2019 (actual)
First posted: 19 Oct 2018 (actual)
Results: Posted 14 Mar 2022

Clinical summary

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

The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.

Study design

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

Arm	Type	Receives
Test Lens	Experimental	Device: Toric Multifocal etafilcon A with PVPSubjects between the ages 40 to 70 years of age and who are adapted contact lens wearers with astigmatism in both eyes will be assigned to the same Test Lens according to the lens wear schedule.

Who may qualify

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

Key inclusion criteria (11 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

Key exclusion criteria (16 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in 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
Toric Multifocal etafilcon A with PVPInvestigational	Device	Test Lens

Primary outcome

Distance Visual Acuity (logMAR)
Time frame: 2-Week Follow-up
High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Near Visual Acuity (logMAR)
Time frame: 2-Week Follow-up
High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.

Results and safety

Results posted to the registry on 14 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Toric Multifocal Etafilcon A With PVP	28	25

Primary outcome: Distance Visual Acuity (logMAR)

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Toric Multifocal Etafilcon A With PVP n = 23
Value	-0.13 (0.095)

Toric Multifocal Etafilcon A With PVP: Least-square mean: -0.131 (95% CI -0.208 to -0.054), Linear Mixed Model

Population analysed: All sub jects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.

Primary outcome: Near Visual Acuity (logMAR)

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Toric Multifocal Etafilcon A With PVP n = 23
Value	0.06 (0.080)

Toric Multifocal Etafilcon A With PVP: Least-square means: 0.060 (95% CI -0.017 to 0.137), Linear Mixed Model

Population analysed: All subjects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.

Adverse events

Time frame: Throughout the duration of the study. Approximately 2 weeks per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Toric Multifocal Etafilcon A With PVP	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
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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.

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 Toric Multifocal etafilcon A with PVP in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. 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 11 inclusion and 16 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 25 Apr 2025. 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 14 Mar 2022). 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?

Distance Visual Acuity (logMAR) (time frame: 2-Week Follow-up). 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 NCT03713281.

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 25 Apr 2025.