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N/A N=51 Randomized Double-blind Treatment

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Refractive Error

Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Visual Acuity (VA) — -0.08; -0.09; -0.09; -0.09 logMAR

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
FID122819 contact lenses (Device); Stenfilcon A contact lenses (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
May 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity (VA)
-0.08; -0.09; -0.09; -0.09

Summary

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign an IRB-approved Informed Consent Form;
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
  • Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
  • Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

  • Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • History of refractive surgery or plan to have refractive surgery during the study;
  • Ocular or intraocular surgery within the previous 12 months or planned during the study;
  • Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
  • Any previous or current wear of MYDAY;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;
  • Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03095027). 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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