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N/A N=66 Randomized Double-blind Supportive Care

Effect of FID 114675A on Lens Wettability

Contact Lens Wettability

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Lens Wettability — 95.5; 97.0 percentage of lenses

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
FID 114675A multi-purpose disinfecting solution (MPDS) (Device); Soft contact lens (Device); Blister pack solution (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Feb 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Wettability
95.5; 97.0

Summary

The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.

Eligibility Criteria

Inclusion Criteria

  • 18 years or age or older with normal eyes, other than correction for refractive error.
  • At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
  • Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
  • Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
  • Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
  • Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
  • History or current ocular infections or ocular inflammatory events.
  • Ocular surgery within the past year.
  • Participation in any investigational study within the past 30 days.
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01342107). 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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