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OpenTrials
Completed

NCT Number: NCT00733291

Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

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Key information

Conditions

Myopia 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

About this study

Corneal staining and subjective responses for ocular redness and comfort will be compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older.
  • Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
  • Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • History of hypersensitivity to any components of the multi-purpose solution.
  • Evidence or history of ocular conditions as prescribed in protocol.
  • One functional eye or a monofit lens
  • Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
  • Significant corneal staining at visit 1 of each study period as prescribed in protocol.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Nelfilcon A contact lens

Device

Commercially marketed, single vision, soft contact lens for daily disposable wear

Other names: Focus Dailies with AquaRelease

Etafilcon A contact lens

Device

Commercially marketed, single vision, soft contact lens for daily disposable wear

Other names: 1-Day ACUVUE Moist

FID 107027 solution

Device

Commercially marketed solution for contact lens disinfection

Other names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution

Primary outcomes

  1. Average Corneal Staining Area

    Time frame: After 2 hours of wear

    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 fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.

  2. Total Corneal Staining Type

    Time frame: After 2 hours of wear

    Total 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.

Secondary outcomes

  1. Ocular Comfort

    Time frame: After 2 hours of wear

    Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable.

  2. Ocular Redness

    Time frame: After two hours of wear

    Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Dec 28, 2011

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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