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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Nelfilcon A contact lens; Device: FID 107027 solution; Device: Etafilcon A contact lens

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nelfilcon A soak / Nelfilcon A no-soak; Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.	Device: Nelfilcon A contact lens; Commercially marketed, single vision, soft contact lens for daily disposable wear; Other Names: Focus Dailies with AquaRelease; Device: FID 107027 solution; Commercially marketed solution for contact lens disinfection; Other Names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
Active Comparator: Nelfilcon A no soak / nelfilcon A soak; Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.	Device: Nelfilcon A contact lens; Commercially marketed, single vision, soft contact lens for daily disposable wear; Other Names: Focus Dailies with AquaRelease; Device: FID 107027 solution; Commercially marketed solution for contact lens disinfection; Other Names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
Active Comparator: Etafilcon A soak / etafilcon A no soak; Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.	Device: FID 107027 solution; Commercially marketed solution for contact lens disinfection; Other Names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution; Device: Etafilcon A contact lens; Commercially marketed, single vision, soft contact lens for daily disposable wear; Other Names: 1-Day ACUVUE Moist
Active Comparator: Etafilcon A no soak / etafilcon A soak; Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.	Device: FID 107027 solution; Commercially marketed solution for contact lens disinfection; Other Names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution; Device: Etafilcon A contact lens; Commercially marketed, single vision, soft contact lens for daily disposable wear; Other Names: 1-Day ACUVUE Moist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After 2 hours of wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After two hours of wear

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 11, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): December 28, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Daily disposable contact lenses; Multi-purpose disinfecting solutions
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Pharmaceutical Solutions
• Other Study ID Numbers: MS-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No