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N/A N=39 Randomized Single-blind Treatment

Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

Myopia

Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) — 13.56; 12.0; 11.86 seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Delefilcon A contact lens (Device); Narafilcon A contact lens (Device); Filcon II 3 contact lens (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
13.56; 12.0; 11.86

Summary

The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.

Eligibility Criteria

Inclusion Criteria

  • Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
  • Require vision correction in both eyes.
  • Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
  • Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
  • Willing and able to wear study contact lenses 16 hours per day.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
  • Require monovision correction.
  • Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Ocular surgery/trauma within the last 6 months.
  • Topical or systemic antibiotic use within 7 days of enrollment.
  • Topical ocular or systemic corticosteroid use within 14 days of enrollment.
  • Pregnant and nursing women.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01548833). 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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