Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 2

Not Applicable

Completed

• Conditions: Visual Acuity
• Interventions: Device: senofilcon A Multifocal; Device: senofilcon A Sphere; Device: etafilcon A Multifocal; Device: etafilcon A Sphere

• Registration Number: NCT03586648
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 60 eligible hyperopic subjects will be targeted to complete this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Disposition First Submitted: 2019-08-20
• Status Verified: 2020-04
• Results First Submitted: 2020-04-10
• Results First Submitted QC: 2020-05-01
• Disposition First Submitted QC: 2020-05-01
• Last Update Submitted: 2020-05-01
• Results First Posted: 2020-05-13
• Disposition First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Potential subjects must satisfy all 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 40 and 70 years of age (inclusive).
  4. The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D in each eye.
  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.
  7. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.
  8. Subjects must own a wearable pair of 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 of more duration).
  10. The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not 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. Currently pregnant or lactating.
  2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  3. 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).
  4. 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.
  5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
  6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  7. A history of amblyopia, strabismus or binocular vision abnormality.
  8. Any current ocular infection or inflammation.
  9. Any current ocular abnormality that may interfere with contact lens wear.
  10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
  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 or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  15. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution or Eye-Cept® rewetting drop solution.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test/Control	senofilcon A Multifocal	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Control/Test	etafilcon A Multifocal	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Control/Test	etafilcon A Sphere	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Test/Control	senofilcon A Sphere	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Test/Control	etafilcon A Sphere	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Control/Test	senofilcon A Sphere	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Test/Control	etafilcon A Multifocal	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Control/Test	senofilcon A Multifocal	Hyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.

Primary Outcome Measures

Name	Time	Method
Vision Scores	2-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.
Vision Scores Comparison Between Test and Control	2-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 (6)

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Dr. James E. Weber; 🇺🇸 Jacksonville, Florida, United States

Maitland Vision Center; 🇺🇸 Maitland, Florida, United States

Wayne Golden, OD; 🇺🇸 Sarasota, Florida, United States

Western Reserve Vision Care; 🇺🇸 Beechwood, Ohio, United States

Procare Vision Center; 🇺🇸 Granville, Ohio, United States