CompletedNCT05433571Updated Jul 27, 2023Results posted

Evaluation of Rotation With a Multifocal Toric Contact Lens

An interventional study of Test Lens in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 5 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 102
Allocation: Randomized
Ages: 40 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Visual Acuity

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 2 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) have results posted.

Browse Johnson & Johnson Vision Care, Inc. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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).
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.

Exclusion criteria

Exclusion Criteria:

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.
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 102 participants (actual)

Study arms

Experimental
Myopes - Against the Rule Sequence 1
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.
Device: Test Lens
Experimental
Myopes - Against the Rule Sequence 2
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.
Device: Test Lens
Experimental
Myopes - With the Rule Sequence 1
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.
Device: Test Lens
Experimental
Myopes - With the Rule Sequence 2
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.
Device: Test Lens
Experimental
Hyperopes - Against the Rule Sequence 1
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.
Device: Test Lens
Experimental
Hyperopes - Against the Rule Sequence 2
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.
Device: Test Lens
Experimental
Hyperope - With the Rule Sequence 1
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.
Device: Test Lens
Experimental
Hyperope - With the Rule Sequence 2
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.
Device: Test Lens

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 15-minutes post lens insertion

Results

Posted Jul 27, 2023

Participant flow

Period 1

Participant flow — Period 1
Milestone	Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)	Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)
Started	53	49
Completed	53	49
Not completed	0	0

Period 2

Participant flow — Period 2
Milestone	Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)	Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)
Started	53	49
Completed	53	49
Not completed	0	0

Outcome measures

PrimaryProportion 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.

Time frame:: 15-minutes post lens insertion
Reported as:: Number · Proportion

Proportion of Eyes With Absolute Rotation ≤ 10 Degrees
Proportion	Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low DC)	Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC)
Proportion of Eyes With Absolute Rotation ≤ 10 Degrees	0.9167	0.8873

Statistical analysis

Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low DC) · Bootstrapping Methods · Mean population estimate: 0.917 · 95% CI 0.878 to 0.955bias adjusted confidence intervals
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC) · Bootstrapping Methods · Mean population estimate: 0.887 · 95% CI 0.845 to 0.930bias adjusted confidence intervals

Adverse events

Collected over Throughout the duration of the study. Approximately 1-Day per Subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low C)	0/102 (0%)	0/102 (0%)	0/102 (0%)
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC)	0/102 (0%)	0/102 (0%)	0/102 (0%)

Baseline characteristics

All subjects dispensed at least one study lens.

Age, Continuous
Age, Continuous(years)	Total
Mean	52.3 ± 8.11

Sex: Female, Male
Sex: Female, Male(Participants)	Total
Female	81
Male	21

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Total
Asian	2
Black or African American	6
White	93
Other	1

Region of Enrollment
Region of Enrollment(Participants)	Total
United States — participants	102

Study locations

5 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Jun 2, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

Data sharing details ↗ · yoda.yale.edu

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in Jul 2022, 0 months.

Results were first posted in Jul 2023, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 21, 2022
First posted: Jun 27, 2022
StartActual: Jun 28, 2022
Primary completionActual: Jul 22, 2022
CompletionActual: Jul 22, 2022
Results first posted: Jul 27, 2023
Last update: Jul 27, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05433571
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Responsible party: Sponsor
First posted: Jun 27, 2022
Start date: Jun 28, 2022
Primary completion: Jul 22, 2022
Completion: Jul 22, 2022
Results posted: Jul 27, 2023
Last update: Jul 27, 2023

Study contacts

Johnson & Johnson Vision Care, Inc. Clinical Trial

study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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