Characterizing Successful Myopic Multifocal Contact Lens Wearers

NCT04178772 | Terminated Results FDA Device

• 1 other identifier: CR-5945
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective, single group, single-arm, and bilateral dispensing study. Subjects will be assigned to a single study lens type to be worn bilaterally in daily wear, and daily disposable modality, for at least 6 hours per day every day for approximately 12 weeks.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Quest Questionnaire Classification Summary

  Subjects are classified into 1 of 4 mutually exclusive groups based on their responses to 6 individual items. 5 items were assessed using the 7-point like-rt scale. A composite score "Life Satisfaction" was calculated for each subject by summing their responses, the final score ranges 0-35 points. Where higher scores indicate higher satisfaction with life. The final item was assessed using a 5 point like-rt scale. If a subject scored 26 or higher for the composite score and responded positively (4 or 5) to the final item, then a subject was classified as "Content \& Driven". If a subject scored 26 or higher but did not respond positively, then "Content \& Indifferent". If a subject scored lower than 26 and responded positively, then "Discontented \& Driven". Lastly, if a subject scored lower than 26 but did not respond positively, then "Discontented \& Indifferent". The percentage of subjects for each group was reported.

  Baseline

• Proportion of Successful Lens Wearers

  Successful lens wearers were defined as subjects that fit the following criteria: 1.Completed all required study visits, 2. responded Excellent or Very Good to both the individual questionnaire items (Overall quality of vision and Overall Comfort) and 3. the investigator would recommend the study lenses. Overall quality of Vision and Overall Comfort are individual questionnaire items with the response set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Investigator recommendation was determined by the individual item "In your opinion, is it suitable to prescribe contact lenses for this subject? (Yes/No)". The proportion of successful lens wearers was reported.

  12-Week Follow-up

Secondary Outcomes (15)

• Monocular Contrast Threshold

  Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

• Binocular Contrast Threshold

  Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

• Photopic Pupillometry

  Baseline, 1-Week Follow-up

• Scotopic Pupillometry

  Baseline, 1-Week Follow-up

• Near Stereopsis Threshold

  Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Study Arms (1)

JJVC Marketed Contact Lens

EXPERIMENTAL

Eligible subjects that have no experience with soft multifocal lenses for more than 2 years will be assigned to a single study lens type worn in both eyes daily for at least 6 hours per day, everyday for approximately 12 weeks.

Device: Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens

Interventions

Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens DEVICE

JJVC Marketed Contact Lens

JJVC Marketed Contact Lens

Eligibility Criteria

• Age: 40 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:
• The participant must 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.
• Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to volunteer.
• Had a self-reported eye examination in the last two years.
• The subject must either already be wearing a presbyopic correction (e.g., reading spectacles over contact lenses, or multifocal spectacles, etc.) or respond positively to at least one symptom on the 'Presbyopic Symptoms Questionnaire".
• Can achieve best corrected distance monocular visual acuity of at least +0.20 logMAR and binocular visual acuity of at least +0.10 logMAR with refraction.
• Have a refractive cylinder of ≤1.00 D in each eye.
• Has corrected best sphere equivalent distance refraction in the range -0.50 D of -6.00 D in each eye (vertex corrected if greater than -4.00D).
• Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye.
• Have a wearable pair of spectacles (at the discretion of the investigator) to wear when they cannot wear the study lenses.

You may not qualify if:

• Potential Subjects who meet any of the following criteria will be excluded from participating in the study:
• Participation in any contact lens or lens care clinical trial within 1 week prior to study enrollment.
• Employee or immediate family member of an employee of the Centre for Ocular Research \& Education listed on the study Delegation Log (e.g., Investigator, Coordinator, Technician).
• Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of enrollment.
• Has any known active ocular disease and/or allergies, ocular infections or other abnormalities that are known to interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or corneal distortion.
• Is using any topical ocular medications other than lubricating eye drops.
• Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
• Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
• Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear film e.g., rheumatoid arthritis, diabetes.
• Had a change within the previous 3 months to the dosage of a systemic medication known to affect ocular prescription or ocular surface or tear film (e.g., steroids) that in the opinion of the investigator may affect a study outcome variable.
• Has undergone cataract or refractive error surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or has any planned (during the study) major surgery (e.g. hip replacement), or any planned ocular surgery (e.g. cataract or refractive error surgery).
• Is a current rigid contact lens wearer, or is wearing contact lenses on extended wear basis, or has a history of extended wear in the past 6 months.
• Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs.
• Has a constant unilateral strabismus at both far and near distances, or has anisometropia \>2 D between both eyes, or has amblyopia.
• Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study (Refresh Plus® rewetting drop solution, Sodium Fluorescein or Alcon Clear Care Cleaning System).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Centre for Ocular Research and Education, University of Waterloo

Waterloo, Ontario, Canada

Location

Results Point of Contact

• Title: Thomas Karkkanien - Sr. Principal Research Optometrist
• Organization: Johnson & Johnson VIsion Care, Inc.

TKarkkai@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: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: November 4, 2019
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: March 23, 2022
• Results First Posted: March 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)