Clinical Evaluation of Fitting Investigational Contact Lenses

NCT03150485 | Completed Results FDA Device

• 1 other identifier: CR-5913
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• The Average Number of Fitting Modifications to Optimize Vision

  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.

  15 minutes post lens insertion

Secondary Outcomes (10)

• Subject's Responses to Individual Item 1

  15 Minuted Post Lens Insertion

• Subject's Responses to Individual Item 2

  15 Minuted Post Lens Insertion

• Subject's Responses to Individual Item 3

  15 Minuted Post Lens Insertion

• Subject's Responses to Individual Item 4

  15 Minuted Post Lens Insertion

• Subject's Responses to Individual Item 5

  15 Minuted Post Lens Insertion

Study Arms (2)

etafilcon A Toric Multifocal

EXPERIMENTAL

Device: JJVC Fitting Guides

etafilcon A Multifocal

ACTIVE COMPARATOR

Device: JJVC Fitting Guides

Interventions

JJVC Fitting Guides DEVICE

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.

etafilcon A Multifocal; etafilcon A Toric Multifocal

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
• 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".
• 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).
• 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.
• 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.
• The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
• The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
• The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
• The subject must have a wearable pair of spectacles if required for their distance vision.

You may not qualify if:

• Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
• Pregnancy or lactation.
• Currently diagnosed with diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
• 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.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
• Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
• A history of amblyopia, strabismus or binocular vision abnormality.
• Any ocular infection or inflammation.
• Any ocular abnormality that may interfere with contact lens wear.
• Use of any ocular medication, with the exception of rewetting drops.
• History of herpetic keratitis.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Vistakon Research Clinic

Jacksonville, Florida, 32256, United States

Location

Results Point of Contact

• Title: Thomas Karkkainen - SR PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision

TKarkkai@its.jnj.com

904 443-3402

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 12, 2017
• Study Start: March 27, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 29, 2018
• Results First Posted: June 29, 2018

Record last verified: 2018-05

Locations

US (1)