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N/A Completed N=128 Randomized Double-blind Treatment

Evaluation of Etafilcon A Daily Disposable Lenses

Source: ClinicalTrials.gov NCT02061592 ↗
Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Overall Comfort — 60.1; 43.6 units on a scale

Summary

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Comfort
60.1; 43.6 —
PRIMARY
Overall Vision
64.9; 58.0 —
PRIMARY
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
0.030; 0.020 —
PRIMARY
Monocular logMar Visual Acuity - Standard Low Contrast Bright
0.060; 0.050 —

Eligibility Criteria

Inclusion Criteria

  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be at least 18 and not more than 70 years of age.
  • The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.
  • The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
  • The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
  • The subject must self-report their race as Asian
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  • The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

Exclusion Criteria

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.).
  • 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.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Monovision or multi-focal 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 a contagious immunosuppressive disease (e.g., HIV, by self report).
  • Suspicion of or recent history of alcohol or substance abuse.
  • History of serious mental illness.
  • History of seizures.
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02061592). 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. Informational only — not medical advice.

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