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Completed

NCT Number: NCT01476722

Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)

The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.

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Key information

Conditions

Healthy

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

  • Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;
  • Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;
  • Read, sign, and date IRB-approved informed consent and privacy document;
  • Be generally healthy and have normal ocular health;
  • Willing to follow the study procedures and visit schedule;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Wear lenses on an extended wear basis during the study;
  • Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;
  • Monocular subject;
  • Requirestoric or multifocal contact lenses;
  • Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
  • Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
  • Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination;
  • Ocular surgery within the 12 months prior to Visit 1;
  • Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study;
  • Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day;
  • Participation in any clinical study within 30 days of Visit 1;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

OPTI-FREE PureMoist multipurpose disinfecting solution

Device

FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days

Primary outcomes

  1. Corneal Fluorescein Staining Type at Baseline

    Time frame: Day 0 (Baseline)

    Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.

  2. Corneal Fluorescein Staining Type at Day 30

    Time frame: Day 30

    Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.

  3. Corneal Fluorescein Staining Area at Baseline

    Time frame: Day 0 (Baseline)

    Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.

  4. Corneal Fluorescein Staining Area at Day 30

    Time frame: Day 30

    Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Lens Wearing Experience and Biocompatibility With OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution (OFP MPDS) in Silicone Hydrogel and Soft Contact Lens Wearers (US)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Nov 19, 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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