N/A
N=101
Clinical Evaluation of Investigational Contact Lenses
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT02801396 ↗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
| Outcome | Result | p-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.
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.