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N/A Completed N=113 Randomized Single-blind Treatment

Comparison of Two Soft Bifocal Contact Lenses

Source: ClinicalTrials.gov NCT00724945 ↗
Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Distance Visual Acuity — -0.08591; -0.10267 logMAR units

Summary

The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Distance Visual Acuity
-0.08591; -0.10267
PRIMARY
Near Visual Acuity
0.02711; 0.01933
PRIMARY
Subject Vision
3.4594; 3.3853

Eligibility Criteria

Inclusion Criteria

  • The subject must between 35 and 70 years of age.
  • The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.
  • The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
  • Refractive cylinder must be -0.75 D in each eye.
  • The subject must have an ADD power of +0.75D to +2.50D in each eye.
  • The subject must have best corrected visual acuity of 20/20-3 or better in each eye
  • The subject's must have at least 20/30-distance vision OU with the study contact lenses.
  • The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses
  • The subject must be an adapted soft contact lens wearer in both eyes.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria

  • Ocular or systemic allergies or disease that may interfere with contact lens wear.
  • Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear
  • Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation
  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of diabetes
  • History of binocular vision abnormality or strabismus
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00724945). 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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