Effects of Multifocal Contact Lens on Ocular Tissue

NCT02345720 | Completed Results

• 1 other identifier: CR-5632
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (3)

• Upper Eye Lid Margin Staining

  Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.

  30 days Post wear

• Limbal Staining

  Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.

  30 Days Post Wear

• Corneal Staining

  The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.

  30 Days Post Wear

Study Arms (1)

etafilcon - PVP (multi-focal)

EXPERIMENTAL

The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.

Device: etafilcon - PVP (multi-focal)

Interventions

etafilcon - PVP (multi-focal) DEVICE

The investigational contact lens must be worn at least six hours daily.

etafilcon - PVP (multi-focal)

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.
• The subject must be between 40 and 70 years of age.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.
• The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
• The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
• The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
• The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
• Subjects own a wearable pair of spectacles, if required for their distance vision.
• The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).
• The subject must 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".

You may not qualify if:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
• Any ocular or systemic allergies that contraindicate contact lens wear.
• Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.
• Any ocular abnormality that may interfere with contact lens wear.
• Use of any ocular medications, with the exception of rewetting drops.
• Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
• Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
• History of herpetic keratitis.
• Any ocular infection or inflammation.
• Any corneal distortion or irregular cornea.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
• History of diabetes.
• Habitual wearer of etafilcon-A contact lens material.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

London, SW1E6AU, United Kingdom

Location

Results Point of Contact

• Title: Tom Karkkainen, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care Inc.

TKarkkai@its.jnj.com

904-443-3500

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: October 5, 2016

Record last verified: 2016-10

Locations

GB (1)