Clinical Evaluation of Fitting Investigational Contact Lenses

• ClinicalTrials.gov Identifier: NCT03150485
• Recruitment Status: Completed
• First Posted: May 12, 2017
• Results First Posted: June 29, 2018
• Last Update Posted: June 29, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Device: JJVC Fitting Guides	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Fitting Investigational Contact Lenses
• Actual Study Start Date: March 27, 2017
• Actual Primary Completion Date: March 31, 2017
• Actual Study Completion Date: March 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: etafilcon A Toric Multifocal	Device: JJVC Fitting Guides; Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
Active Comparator: etafilcon A Multifocal	Device: JJVC Fitting Guides; Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.

Outcome Measures

Primary Outcome Measures :

1. The Average Number of Fitting Modifications to Optimize Vision [ Time Frame: 15 minutes post lens insertion ]
   The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported.

Secondary Outcome Measures :

1. Subject's Responses to Individual Item 1 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?". This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported.
2. Subject's Responses to Individual Item 2 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?". This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported.
3. Subject's Responses to Individual Item 3 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?". This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported.
4. Subject's Responses to Individual Item 4 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.". The percentage of subject's in each response category was reported.
5. Subject's Responses to Individual Item 5 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?". This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported.
6. Subject's Responses to Individual Item 6 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "What Are Your Current Vision Correction Solutions?". The percentage of subject's in each response category was reported.
7. Subject's Responses to Individual Item 7 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?". This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported.
8. Subject's Responses to Individual Item 8 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?". This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported.
9. Subject's Responses to Individual Item 9 [ Time Frame: 15 Minuted Post Lens Insertion ]
   Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
10. Subject's Responses to Individual Item 10 [ Time Frame: 15 Minuted Post Lens Insertion ]
    Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.

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".
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 distance spherical equivalent or spherical component (if fit with a toric lens) of their refraction must be in the range -1.25 D to -3.75 D in each eye.
7. The subject's refractive cylinder must be 0.00 D to -1.50 D in at least one eye and no greater than -1.50 D in either 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 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, 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)

Contacts and Locations

Locations

United States, Florida

Vistakon Research Clinic

Jacksonville, Florida, United States, 32256

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 14, 2017

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03150485
• Other Study ID Numbers: CR-5913
• First Posted: May 12, 2017
• Results First Posted: June 29, 2018
• Last Update Posted: June 29, 2018
• Last Verified: May 2018

• 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

Additional relevant MeSH terms:

Seizures; Neurologic Manifestations; Nervous System Diseases