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N/A N=132 Randomized Double-blind

DW Evaluation of Lotrafilcon B Lenses in a Modified Design

Myopia

Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes — 100.0; 100.0; 100.0; 100.0 percentage of subjects

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lotrafilcon B sphere modified design contact lenses (Device); Lotrafilcon B sphere contact lenses (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Jul 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
100.0; 100.0; 100.0; 100.0

Summary

The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.

Eligibility Criteria

Inclusion Criteria

  • Must sign an Informed Consent Document;
  • Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
  • Manifest cylinder less than or equal to 0.75 D;
  • Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
  • Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
  • Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;
  • Other protocol-defined criteria may apply.

Exclusion Criteria

  • Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
  • Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear;
  • History of herpetic keratitis;
  • History of corneal or refractive surgery or irregular cornea;
  • A pathologically dry eye that precludes contact lens wear;
  • Monocular (only one eye with functional vision);
  • Monovision correction;
  • History of intolerance or hypersensitivity to any component of the test articles or associated materials;
  • Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;
  • Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02157909). 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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