Characterizing Successful Myopic Multifocal Contact Lens... | NCT04178772

NCT04178772

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens	Device	JJVC Marketed Contact Lens	JJVC Marketed Contact Lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Monocular Contrast Threshold	Monocular Contrast threshold was measured at Distance (4 meter) for both the left and right eyes using the M&S clinical trial suit (CTS) under standard room illumination. Contrast threshold was collected at Baseline, post lens fitting, 2-week follow-up evaluation and the 12-week evaluation. Contrast threshold at baseline was measured while wearing a spherical-cylinder refraction in a trial frame. The M&S system displayed the contrast threshold score in log units. The average contrast threshold was reported for each timepoint.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Potential Subjects must satisfy all of the following criteria to be enrolled in the study:
1. The participant must 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. Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to volunteer.
4. Had a self-reported eye examination in the last two years.
5. 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".
6. 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.
7. Have a refractive cylinder of ≤1.00 D in each eye.
8. 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).
9. Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye.
10. Have a wearable pair of spectacles (at the discretion of the investigator) to wear when they cannot wear the study lenses.
  
  Exclusion Criteria:
Potential Subjects who meet any of the following criteria will be excluded from participating in the study:
1. Participation in any contact lens or lens care clinical trial within 1 week prior to study enrollment.
2. 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).
3. Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of enrollment.
4. 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.
5. Is using any topical ocular medications other than lubricating eye drops.
6. Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
7. 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.
8. Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear film e.g., rheumatoid arthritis, diabetes.
9. 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.
10. 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).
11. 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.
12. Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs.
13. Has a constant unilateral strabismus at both far and near distances, or has anisometropia >2 D between both eyes, or has amblyopia.
14. 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).
15. Has any Grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the biomicroscopy classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear (at the discretion of the investigator).

Name	Affiliation	Role
Johnson & Johnson Vision Care, Inc. Clinical Trial	Johnson & Johnson Vision Care, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Ocular Research and Education, University of Waterloo		Waterloo	Ontario		Canada

ID	Title	Description
FG000	Etafilcon A Multifocal Lens	Subjects that wore the etafilcon A lens during any point of the study.

ID	Title	Description
BG000	Dispensed Subject	All subjects dispensed a study lens.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

All subjects dispensed a study lens.

Posted

Number

Percentage of Participants

Baseline

ID	Title	Description