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N/A N=65 Randomized Treatment

Ocular Characteristics in Contact Lens and Spectacle Wear

Visual Acuity

Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) — 8.28; 11.10 Seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Spectacles (Device); ACUVUE OASYS®1-Day with HydraLuxe™ Technology (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT)
8.28; 11.10
SECONDARY
Total Scores of Meibomian Gland Expressibility (MGE)
8.5; 8.5
SECONDARY
Conjunctival Staining
41; 59; 34; 23; 7; 0
SECONDARY
Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy
36; 31; 15; 19; 29; 30
SECONDARY
Meibomian Gland Expressibility (MGE) Grades
0; 0; 0; 0; 10; 6

Summary

This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.

Eligibility Criteria

Inclusion Criteria

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  • The subject will have completed the pre-screening Classification questionnaire.
  • Subject must have a working cell phone capable of sending and receiving text messages.
  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Between 18 and 42 (inclusive) years of age at the time of screening
  • Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
  • Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
  • Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
  • The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
  • The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
  • Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
  • Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD & OS.

Exclusion Criteria

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or lactating, by self-report
  • Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
  • Any active ocular abnormalities/conditions that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  • Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
  • Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
  • Habitual spectacle contains an add power, photochromic or tint.
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  • Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  • Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician)
  • Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator)
  • Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
  • 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 (CTP-2018).
  • Accommodative/binocular dysfunction, determined by study procedures.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03913377). 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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