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

Alcon Research64 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

Nelfilcon A contact lensDEVICE

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

Etafilcon A contact lensDEVICE

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

FID 107027 solutionDEVICE

Commercially marketed solution for contact lens disinfection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Average Corneal Staining Area

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.

Time frame: After 2 hours of wear

Total Corneal Staining Type

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.

Time frame: After 2 hours of wear

Secondary Outcomes

Ocular Comfort

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.

Time frame: After 2 hours of wear

Ocular Redness

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.

Time frame: After two hours of wear

Data from ClinicalTrials.gov

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