Evaluation of Rotation With a Multifocal Toric Contact Lens

NCT05433571 | Completed Results FDA Device

• 1 other identifier: CR-6491
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 5

Brief 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

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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.

  15-minutes post lens insertion

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Device: Test Lens

Interventions

Test Lens DEVICE

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

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (5)

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

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

Manhattan, New York, 10022, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: Ross Franklin
• Organization: Johnson & Johnson Vision Care (JJVC)

RFRANKL1@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: June 28, 2022
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (5)