Clinical trial NCT04178772: Characterizing Successful Myopic Multifocal Contact Lens Wearers
Official title: Characterizing Successful Myopic Multifocal Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Quest Questionnaire Classification Summary
timeFrame: Baseline
measure: Proportion of Successful Lens Wearers
timeFrame: 12-Week Follow-up
Secondary outcomes:
measure: Monocular Contrast Threshold
timeFrame: Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up
measure: Binocular Contrast Threshold
timeFrame: Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up
measure: Photopic Pupillometry
timeFrame: Baseline, 1-Week Follow-up
measure: Scotopic Pupillometry
timeFrame: Baseline, 1-Week Follow-up
measure: Near Stereopsis Threshold
timeFrame: Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up
measure: Blur Tolerance
timeFrame: Baseline
measure: Fixation Disparity With Refraction
timeFrame: Baseline
measure: Non-invasive Tear Break-up Time
timeFrame: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up
measure: Coma
timeFrame: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up
measure: Higher Order Aberration
timeFrame: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up
measure: Keratometry (Diopters)
timeFrame: Baseline
measure: Keratometry (Degrees)
timeFrame: Baseline
measure: Objective Accommodation With Distance Refraction
timeFrame: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up
measure: Binocular Visual Acuity (logMAR)
timeFrame: 10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up
measure: Monocular Visual Acuity (logMAR)
timeFrame: 10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research and Education, University of Waterloo
state: Ontario
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: