Mode
Text Size
Log in / Sign up
N/A N=98 Randomized Single-blind Treatment

Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Myopia

Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Papillary Conjunctivitis — 0.98; 0.47 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Narafilcon B Contact Lens (Device); Spectacles (Device)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Apr 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Papillary Conjunctivitis
0.98; 0.47
PRIMARY
Conjunctival Hyperemia
0.26; 0.28
PRIMARY
Limbal Hyperemia
0.56; 0.30
PRIMARY
Corneal Staining
0.26; 0.12
PRIMARY
Conjunctival Staining
1.41; 0.39
PRIMARY
Corneal Neovascularization
0.30; 0.09
PRIMARY
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
-4.97; 0.62
SECONDARY
Comfortable Wearing Time
10.25

Summary

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Eligibility Criteria

Inclusion Criteria

  • Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
  • Willing to comply with the study visit schedule.
  • Ages 15 to 39.
  • Has access to a cellular telephone with text messaging capabilities.
  • Has a current pair of spectacles.
  • 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
  • Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
  • Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
  • Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
  • They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria

  • Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
  • Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
  • Systemic disease, which might interfere with contact lens wear.
  • Medication usage that may be associated with eye dryness.
  • Use of any topical medication such as eye drops or ointment.
  • Pregnant or lactating (by self-report).
  • Aphakia.
  • Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
  • Have participated in any other clinical trial or research in the two weeks prior to starting this study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01093625). 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.

Back to search