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N/A Completed N=49 Randomized Single-blind Treatment

Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

Source: ClinicalTrials.gov NCT01007916 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcomePrimary: Comfort Upon Insertion — 8.7; 9.2 Units on a Scale

Summary

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort Upon Insertion
8.7; 9.2

Eligibility Criteria

Inclusion Criteria

  • Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
  • Wears lenses at least 5 days per week and at least 12 hours per day.
  • Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
  • Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
  • Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
  • Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Currently sleeping in contact lenses for more than 6 consecutive nights.
  • Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
  • Other protocol-defined inclusion/exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01007916). 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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