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

Purpose

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.

Condition	Intervention
Myopia	Device: Nelfilcon A contact lens Device: Etafilcon A contact lens Device: FID 107027 solution

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Average Corneal Staining Area [ Time Frame: After 2 hours of wear ] [ Designated as safety issue: No ]
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.
Total Corneal Staining Type [ Time Frame: After 2 hours of wear ] [ Designated as safety issue: No ]
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 Outcome Measures:

Ocular Comfort [ Time Frame: After 2 hours of wear ] [ Designated as safety issue: No ]
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.
Ocular Redness [ Time Frame: After two hours of wear ] [ Designated as safety issue: No ]
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.

Enrollment:	64
Study Start Date:	January 2008
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Focus Dailies with AquaRelease Device: FID 107027 solution Commercially marketed solution for contact lens disinfection Other Name: 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 Name: Focus Dailies with AquaRelease Device: FID 107027 solution Commercially marketed solution for contact lens disinfection Other Name: 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: Etafilcon A contact lens Commercially marketed, single vision, soft contact lens for daily disposable wear Other Name: 1-Day ACUVUE Moist Device: FID 107027 solution Commercially marketed solution for contact lens disinfection Other Name: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
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: Etafilcon A contact lens Commercially marketed, single vision, soft contact lens for daily disposable wear Other Name: 1-Day ACUVUE Moist Device: FID 107027 solution Commercially marketed solution for contact lens disinfection Other Name: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733291

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00733291 History of Changes
Other Study ID Numbers:	MS-008
Study First Received:	August 11, 2008
Results First Received:	April 10, 2009
Last Updated:	December 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Daily disposable contact lenses
Multi-purpose disinfecting solutions

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 13, 2013