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Completed

NCT Number: NCT01342107

Effect of FID 114675A on Lens Wettability

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76314, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FID 114675A multi-purpose disinfecting solution (MPDS)

Device

Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.

Soft contact lens

Device

Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.

Other names: Acuvue2, PureVision, Acuvue Oasys

Blister pack solution

Device

Commercially approved storage solution as found in the contact lens blister pack.

Other names: Acuvue2, PureVision, Acuvue Oasys

Primary outcomes

  1. Lens Wettability

    Time frame: 16 hours

    As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

The Effect of Alcon Multi-Purpose Disinfecting Solution (MPDS) on Lens Wettability

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Apr 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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