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N/A Completed N=267 Randomized Treatment

Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

Refractive Ametropia
Source: ClinicalTrials.gov NCT01484028 ↗
Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Monocular Visual Acuity — -0.044; -0.060 LogMAR score

Summary

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Monocular Visual Acuity
-0.044; -0.060 —
PRIMARY
Lens Fit Acceptance
100; 100 —
PRIMARY
Corneal Staining of Grade 3 or 4
0; 0 —

Eligibility Criteria

Inclusion Criteria

  • Healthy, female adult, at least 18 years of age, and no more than 34 years of age
  • The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
  • Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
  • Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
  • Any cylinder power must be: <=0.75D
  • Visual acuity must be best correctable to 20/25 or better for each eye
  • Must have normal eyes (no ocular medications or ocular infection of any type)
  • Must read and sign the Statement of Informed Consent
  • Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

  • Ocular or systemic allergies or disease which might interfere with contact lens wear
  • Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
  • Any ocular infection
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  • Any color deficiencies (colorblindness) - to the best of the subject's knowledge
  • Pregnancy or lactation
  • Diabetes
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
  • Subject presents with one dark iris color and one light iris color.
  • Subject has heterochromia iridis (a difference in color between parts of one iris).
  • The subject must not be an employee or family member of the clinical study site.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01484028). 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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