Handling Comparison Between Two Contact Lens Types

NCT02310126 | Completed Results

• 1 other identifier: CR-5570
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 8

Brief Summary

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.

  CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

  15 minutes post Contact Lens Insertion

Study Arms (2)

etafilcon A(sphere)/etafilcon A(multi-focal)

ACTIVE COMPARATOR

Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.

Device: etafilcon A (multi-focal); Device: etafilcon A (sphere)

etafilcon A(multi-focal)/etafilcon A(sphere)

ACTIVE COMPARATOR

Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.

Device: etafilcon A (multi-focal); Device: etafilcon A (sphere)

Interventions

etafilcon A (multi-focal) DEVICE

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

Also known as: Investigational Multifocal Contact

etafilcon A(multi-focal)/etafilcon A(sphere); etafilcon A(sphere)/etafilcon A(multi-focal)

etafilcon A (sphere) DEVICE

Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

Also known as: 1-DAY ACUVUE® MOIST®

etafilcon A(multi-focal)/etafilcon A(sphere); etafilcon A(sphere)/etafilcon A(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 +0.25 to +4.00 or plano to -6.00 in each eye.
• The subject's refractive cylinder must be less than or equal to -0.75 D 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 best corrected visual acuity of 20/20 -3 or better in each eye.
• Subject must own a wearable pair of spectacles.
• The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of 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 responded 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 or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Any ocular abnormality that may interfere with contact lens wear.
• Use of any ocular medication, with the exception of rewetting drops.
• Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
• Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
• Any ocular infection or inflammation.
• History of herpetic keratitis.
• Any corneal distortion or irregular cornea.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
• Current history of diabetes.
• 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 (8)

Baymeadows Vision Center

Jacksonville, Florida, 32256, United States

Location

Eye Elements Eyecare

Jacksonville, Florida, 32256, United States

Location

Vistakon Research Clinic

Jacksonville, Florida, 32256, United States

Location

Golden Family Eyecare

Sarasota, Florida, 34232, United States

Location

Eye Associates of Winter Park

Winter Park, Florida, 32792, United States

Location

Central Ohio Eyecare

Columbus, Ohio, 43202, United States

Location

Optometry Group LLC

Memphis, Tennessee, 38111, United States

Location

Nashville Vision Associates

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Thomas R. Karkkainen, O.D., M.S., F.A.A.O., Sr. Principal Research Optometrist
• 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 19, 2018
• Results First Posted: March 31, 2016

Record last verified: 2017-06

Locations

US (8)