Clinical Evaluation of Investigational Multifocal Contact Lenses

• ClinicalTrials.gov Identifier: NCT03059810
• Recruitment Status: Completed
• First Posted: February 23, 2017
• Results First Posted: December 24, 2019
• Last Update Posted: December 24, 2019
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Device: etafilcon A	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Investigational Multifocal Contact Lenses
• Actual Study Start Date: January 27, 2017
• Actual Primary Completion Date: April 25, 2017
• Actual Study Completion Date: April 25, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Participating Subjects; Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits.	Device: etafilcon A; Investigational Contact Lens

Outcome Measures

Primary Outcome Measures :

1. Overall Vision [ Time Frame: 12-16 Day Follow-up ]
   Overall 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
4. 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 if not, respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".(Appendix B).
5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
6. The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
7. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye.
8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.
11. The subject must have a wearable pair of spectacles if required for their distance vision.

Exclusion Criteria:

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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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.

Contacts and Locations

Locations

United States, California

EYE Center Optometric

Rocklin, California, United States, 95677

United States, Florida

Dr. Ted Brink & Associates

Jacksonville, Florida, United States, 32225

Vistakon Research Clinic

Jacksonville, Florida, United States, 32256

Golden Vision

Sarasota, Florida, United States, 34232

Eye Associates of Winter Park

Winter Park, Florida, United States, 32792

United States, Indiana

University of Indiana School of Optometry

Bloomington, Indiana, United States, 47405

United States, New York

Sacco Eye Group

Vestal, New York, United States, 13850

United States, Tennessee

Optometry Group, PLLC

Memphis, Tennessee, United States, 38111

Total Eye Care, PA

Memphis, Tennessee, United States, 38119

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2017

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03059810
• Other Study ID Numbers: CR-5903
• First Posted: February 23, 2017
• Results First Posted: December 24, 2019
• Last Update Posted: December 24, 2019
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes