Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)
1 other identifier
interventional
64
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedResults Posted
Study results publicly available
December 21, 2011
CompletedDecember 28, 2011
December 1, 2011
1 month
August 11, 2008
April 10, 2009
December 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Ocular Comfort
After 2 hours of wear
Ocular Redness
After two hours of wear
Study Arms (4)
Nelfilcon A soak / Nelfilcon A no-soak
ACTIVE COMPARATORNelfilcon 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.
Nelfilcon A no soak / nelfilcon A soak
ACTIVE COMPARATORNelfilcon 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.
Etafilcon A soak / etafilcon A no soak
ACTIVE COMPARATOREtafilcon 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.
Etafilcon A no soak / etafilcon A soak
ACTIVE COMPARATOREtafilcon 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.
Interventions
Commercially marketed, single vision, soft contact lens for daily disposable wear
Commercially marketed, single vision, soft contact lens for daily disposable wear
Commercially marketed solution for contact lens disinfection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 13, 2008
Study Start
January 1, 2008
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
December 28, 2011
Results First Posted
December 21, 2011
Record last verified: 2011-12