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N/A N=113 Randomized Double-blind Treatment

Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)

Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Subject Comfort — 92.4; 92.4; 92.0; 63.0 Units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Opti-Free : RevitaLens / Clear Care : RevitaLens (Device); Opti-Free : RevitaLens / RevitaLens : Clear Care (Device); Clear Care : RevitaLens/ Opti-Free : RevitaLens (Device); Clear Care : RevitaLens / RevitaLens : Opti-Free (Device); RevitaLens : Clear Care/ Opti-Free : RevitaLens (Device); RevitaLens : Clear Care / RevitaLens : Opti-Free (Device); RevitaLens : Opti-Free / Clear Care : RevitaLens (Device); RevitaLens : Opit-Free / RevitaLens : Clear Care (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Subject Comfort
92.4; 92.4; 92.0; 63.0; 93.4; 92.3

Summary

This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.

Eligibility Criteria

Inclusion Criteria

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  • Subjects must be 18-69 years of age (inclusive).
  • Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
  • Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
  • The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
  • The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  • Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators 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 this clinical protocol.

Exclusion Criteria

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or breast-feeding.
  • Diabetes
  • Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
  • Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
  • Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
  • Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
  • Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
  • Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
  • Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
  • Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
  • Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
  • History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
  • Habitual contact lens wear modality as extended wear.
  • Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
  • History of binocular vision abnormality or strabismus.
  • Habitual wearers of rigid gas permeable lens within the past 3 months.
  • Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03466060). 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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