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N/A N=92 Randomized Single-blind Treatment

Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

Visual Acuity

Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Change From Baseline Comfort Score — 28.99; -0.29 Units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ACUVUE Oasys 1-Day (Device); Habitual Lens (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Aug 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline Comfort Score
28.99; -0.29
SECONDARY
Change From Baseline CLDEQ-8 Score
-10.83; -1.23
SECONDARY
Comfort Score
55.88; 29.69
SECONDARY
CLDEQ-8 Score
12.46; 21.18

Summary

This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.

Eligibility Criteria

Inclusion Criteria

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  • 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 59 (inclusive) years of age at the time of screening.
  • Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report.
  • Have a CLDEQ-8 score of 15 or greater with the habitual lens.
  • Subjects must possess a pair of spectacles for distance correction.
  • Subject's habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision® MyDay®, or Johnson & Johnson 1-Day ACUVUE® Moist.
  • The subject's vertex corrected spherical distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
  • The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye.
  • Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Subject's habitual lens is ACUVUE OASYS®1-Day.
  • Currently pregnant or lactating, by self-report.
  • Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
  • Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
  • Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  • 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.
  • . 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 over the counter (OTC)) that may interfere with contact lens wear (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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04849780). 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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