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OpenTrials
Completed

NCT Number: NCT02061592

Evaluation of Etafilcon A Daily Disposable Lenses

To evaluate the clinical performance of daily disposable etafilcon A lenses.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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 at least 18 and not more than 70 years of age.
  • The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.
  • The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
  • The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
  • The subject must self-report their race as Asian
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  • The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

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 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 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 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.
  • History of seizures.
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Treatment and study plan

etafilcon A

Device

Primary outcomes

  1. Overall Comfort

    Time frame: 1-week follow-up

    Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) 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 indicated a more favorable/positive response with a range of 0 to 120.

  2. Overall Vision

    Time frame: 1- week Follow-up

    Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) 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 indicated a more favorable/positive response with a range of 0 to 120.

  3. Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim

    Time frame: 1-week follow-up

    LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.

  4. Monocular logMar Visual Acuity - Standard Low Contrast Bright

    Time frame: 1- week Follow-up

    LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 13, 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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