Clinical Evaluation of Approved Contact Lenses

NCT02699593 | Completed Results DMC FDA Device

• 1 other identifier: CR-5809
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 7

Brief Summary

This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Contact Lens Wearing Time

  Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.

  2-week follow-up

• Visual Acuity (LogMAR)

  Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.

  2-week Follow-up

Study Arms (2)

Test / Control Sequence

EXPERIMENTAL

Subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality.

Device: Test Contact Lens; Device: Control Contact Lens

Control / Test Sequence

ACTIVE COMPARATOR

Subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality.

Device: Test Contact Lens; Device: Control Contact Lens

Interventions

Test Contact Lens DEVICE

Also known as: senofilcon A made with material from a new supplier

Control / Test Sequence; Test / Control Sequence

Control Contact Lens DEVICE

Also known as: senofilcon A made with material from the current supplier

Control / Test Sequence; Test / Control Sequence

Eligibility Criteria

• Age: 18 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 at least 18 and not more than 70 years of age (including 70).
• The subject's refractive cylinder must be \< 0.75 Diopters (D) in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.
• The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.

You may not qualify if:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
• Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Eye Elements Eyecare

Jacksonville, Florida, United States

Location

Golden Vision

Sarasota, Florida, United States

Location

Advantage Eyecare Associates, LLC

Neodesha, Kansas, United States

Location

Advanced Eyecare, PC

Raytown, Missouri, United States

Location

Professional Vision Care

Westerville, Ohio, United States

Location

Timothy R. Poling, OD

Roanoke, Virginia, United States

Location

Results Point of Contact

• Title: Brian Pall, OD, MS, FAAO -Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

BPALL@its.jnj.com

904 443-1290

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 12, 2017
• Results First Posted: June 9, 2017

Record last verified: 2017-06

Locations

US (7)