Evaluation of Two Marketed Multifocal Contact Lenses

Not Applicable

Completed

• Conditions: Visual Performance
• Interventions: Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2; Device: Spherical Contact Lens 2

• Registration Number: NCT03322423
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-26
• Primary Completion: 2017-11-04
• Study Completion: 2017-11-04
• Results First Submitted: 2018-10-31
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Results First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between at least 40 years of age and not greater than 70 years of age.
  4. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
  5. The subject's refractive cylinder must be ≤ -0.75 D in each eye.
  6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
  8. The subject must own a pair of wearable spectacles if required for their distance vision.
  9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
  10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
  2. Pregnancy or lactation.
  3. Currently diagnosed with diabetes.
  4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
  5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
  7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  8. A history of amblyopia, strabismus or binocular vision abnormality.
  9. Any ocular infection or inflammation.
  10. Any ocular abnormality that may interfere with contact lens wear.
  11. Use of any ocular medication, with the exception of rewetting drops.
  12. History of herpetic keratitis.
  13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative	Multifocal Contact Lens 2	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative	Spherical Contact Lens 2	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal	Spherical Contact Lens 2	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal	Multifocal Contact Lens 2	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal	Multifocal Contact Lens 1	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative	Multifocal Contact Lens 1	Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.

Primary Outcome Measures

Name	Time	Method
Distance Binocular Visual Acuity	1-Week Follow-up	Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Near Binocular Visual Acuity	1-Week Follow-up	Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.

Secondary Outcome Measures

Name	Time	Method
Overall Quality of Vision	1-Week Follow-up	Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Trial Locations

Locations (5)

Botetourt Eyecare, LLC; 🇺🇸 Salem, Virginia, United States

Golden Vision; 🇺🇸 Sarasota, Florida, United States

ABQ Eye Care; 🇺🇸 Albuquerque, New Mexico, United States

West Bay Eye Associates; 🇺🇸 Warwick, Rhode Island, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States