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Evaluation of Rotation With a Multifocal Toric Contact Lens | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Rotation With a Multifocal Toric Contact Lens

NCT05433571•Johnson & Johnson Vision Care, Inc.

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.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
•2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
•3. Be at least 40 and not more than 70 years of age at the time of screening.
•4. Own a wearable pair of spectacles with distance vision correction.
•5. 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).
•6. 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.
•7. 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°.
•8. Have best corrected distance visual acuity of 20/25 or better in each eye.

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•1. Be currently pregnant or lactating.
•2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
•3. 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).
•4. 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.
•5. Currently use ocular medication with the exception of rewetting drops.
•6. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, or sodium fluorescein.
•7. Have had any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
•8. Have a history of amblyopia or strabismus.
•9. Have a history of herpetic keratitis.
+8 more criteria

Locations (5)

Stam & Associates Eye Care

Jacksonville, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Center for Ophthalmic and Vision Research/Eye Associates of New York

Manhattan, New York, United States

Tyler Eye Associates

Tyler, Texas, United States

Key Dates

Start Date

June 28, 2022

Primary Completion Date

July 22, 2022

Completion Date

July 22, 2022

Last Updated

July 27, 2023

Enrollment

102

ACTUAL participants

Conditions

Visual Acuity

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Rotation With a Multifocal Toric Contact Lens

Inclusion Criteria

Exclusion Criteria

Effect of Action Video Games and Stroboscopic Glasses on Dynamic Visual Acuity.

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