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N/A Completed N=166 Randomized Double-blind

A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Source: ClinicalTrials.gov NCT01449526 ↗
Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Visual Acuity (VA) — -0.033; -0.038 LogMAR

Summary

The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity (VA)
-0.033; -0.038 —
SECONDARY
Slit Lamp > Grade 2
2; 5 —

Eligibility Criteria

Inclusion Criteria

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be myopic, and wear contact lenses in each eye.
  • Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria

  • Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or who are using any ocular medication.
  • Subjects with any grade 2 or greater finding during the slit lamp examination.
  • Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who are allergic to any component in the study care products.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01449526). 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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