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N/A N=101 Randomized Treatment

Clinical Evaluation of Investigational Contact Lenses

Visual Acuity

Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: CLUE Handling — 55.73; 57.58; 64.39 Units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Etafilcon A Design 1 (Test 1) (Device); Etafilcon A Design 2 (Test 2) (Device); Etafilcon A (Control) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
CLUE Handling
55.73; 57.58; 64.39
PRIMARY
Visual Performance (LogMar)
0.00; 0.00; 0.01
PRIMARY
Percentage of Eyes With Acceptable Mechanical Lens Fit
95; 97; 91
PRIMARY
Percentage of Eyes With Acceptable Cosmetic Lens Fit
99.5; 99.5; 99.5

Summary

Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will complete a questionnaire for each study lens.

Eligibility Criteria

Inclusion Criteria

  • Subjects must be at least 18 years of age and no more than 55 years of age (inclusive).
  • The subject's vertex corrected best spherical distance refraction must be in the range of -1.00 to -6.00 Diopters (D) in each eye.
  • The subject's vertex corrected cylindrical component of distance refraction must be less than or equal to -1.50 Diopters of Cylinder (DC) in each eye.
  • Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
  • Subjects must self-report as being Asian race.
  • Subjects must self-report as having brown or black eyes.
  • Subjects must be habitual lens wearer (clear or limbal ring cosmetic) . Habitual is defined as at least one (1) month of Contact Lens wear where the lenses were worn for a minimum of six (6) hours per day and a minimum of three (3) days per week.
  • Subjects between 18 to 39 years old must be habitual limbal ring cosmetic lens wearers or must have tried limbal ring cosmetic lens within the past two years.
  • Subjects must be cosmetic contact lens concept acceptors as determined by screening questionnaire.
  • Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigator's discretion).
  • Subjects must read, understand, and sign the Statement of Informed Consent.
  • Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
  • Subjects must be willing to have their eyes video recorded and photographed.

Exclusion Criteria

  • Working for any advertising agency, any company involved in public relations or marketing, market research; or any company that makes or sells contact lenses or glasses.
  • Participated in any paid market research within the past 3 months.
  • Pregnant or breast feeding a baby.
  • Subjects with diabetes.
  • Any ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Any systemic disease, or autoimmune disease, which might interfere with contact lens wear, at investigator's discretion.
  • Using medications during and immediately preceding the study period that may interfere with current contact lens wear as determined by the investigators
  • Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  • Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.
  • Any active ocular abnormalities/conditions that might interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection etc.).
  • Any corneal distortion, scar, or opacity affecting vision as noted by subjects or investigators during examination.
  • History of any corneal surgery (e.g. radial keratotomy (RK), photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK)); confirmed with topography if necessary at the investigator's discretion.
  • Habitual wearers of rigid gas permeable or orthokeratology lens within the past 3 months.
  • Current habitual contact lens modality for extended wear or conventional wear (contact lenses with a replacement schedule of 3 months to >1 year).
  • Participation in any pharmaceutical, medical device, or contact lens related clinical research trial within 14 days prior to study enrollment. This excludes studies that do not require product treatment/intervention.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02801396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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