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OpenTrials
Completed

NCT Number: NCT01484938

Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

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, 76134, 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 older
  • Soft contact lens wear on a daily wear basis
  • Able to wear contact lenses for at least 8 hours
  • Generally healthy and have normal ocular health
  • Other protocol-defined inclusion criteria may apply

Exclusion criteria

  • No use of additional lens cleaners
  • No known sensitivities to any ingredient in the test article
  • No history of ocular surgery/trauma within the last six months
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

OPTI-FREE PureMoist

Device

Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses

Primary outcomes

  1. Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30

    Time frame: Baseline (Day 0), Day 30

    Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.

  2. Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30

    Time frame: Baseline (Day 0), Day 30

    Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 5, 2011
Registry last updated
Oct 10, 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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