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N/A N=60 Randomized Single-blind Treatment

The Effects of Contact Lenses With Experimental Dye on Visual Function

Ametropia

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Two-Point Light Spread Function — 5.36; 6.71; 6.47; 7.48 mm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
senofilcon A with new UV blocker (Device); senofilcon A (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Two-Point Light Spread Function
5.36; 6.71; 6.47; 7.48; 2.29; 3.37
PRIMARY
Halos
29.20; 52.57; 39.09; 46.73
PRIMARY
Starburts
45.66; 75.12; 55.78; 69.60
SECONDARY
Glare Disability Threshold
0.98; 1.16
SECONDARY
Photostress Recovery Time
8.83; 17.28
SECONDARY
Glare Discomfort
2.26; 2.90
SECONDARY
Heterochromatic Contrast Threshold
1.01; 1.24

Summary

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

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 65 (inclusive) years of age at the time of screening.
  • Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
  • The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
  • The subject has a best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

  • Currently pregnant or breastfeeding.
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Multifocal, toric or extended wear contact lens correction.
  • Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  • History of binocular vision abnormality or strabismus.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  • Any ocular infection.
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03556579). 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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