Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study

Johnson & Johnson Vision Care, Inc.0 sites23 target enrollmentDecember 2014

ConditionsVisual Acuity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 23
Primary Endpoint: Limbal Staining
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

May 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Limbal Staining

Time Frame: 30 Days Post Wear

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

Corneal Staining

Time Frame: 30 Days Post Wear

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

Upper Eye Lid Margin Staining

Time Frame: 30 days Post wear

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.