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OpenTrials
Completed

NCT Number: NCT02310126

Handling Comparison Between Two Contact Lens Types

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

Completed

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baymeadows Vision Center, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 +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".

Exclusion criteria

  • 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.

Treatment and study plan

etafilcon A (multi-focal)

Device

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

Other names: Investigational Multifocal Contact

etafilcon A (sphere)

Device

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

Other names: 1-DAY ACUVUE® MOIST®

Primary outcomes

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

    Time frame: 15 minutes post Contact Lens Insertion

    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).

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2014
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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