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

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00733291

Purpose

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
Soft Contact Lens Wearers	Device: Day Acuvue Moist or Focus DAILIES with AquaRelease Daily Disposable Lenses, Multi Purpose Solution FID 107027 Device: Day Acuvue Moist or Focus DAILIES with AquaRelease Daily Disposable Lenses

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Crossover Assignment

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:

Corneal staining [ Time Frame: 2 hours of contact lens wear on one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comfort [ Time Frame: 2 hours of contact lens wear on one day ] [ Designated as safety issue: No ]

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
1: Experimental Daily disposable lens pre-soaked in Multi Purpose Solution FID 107027	Device: Day Acuvue Moist or Focus DAILIES with AquaRelease Daily Disposable Lenses, Multi Purpose Solution FID 107027 Lenses inserted after presoak in Multi Purpose Solution FID 107027
2: Active Comparator Daily disposable lens inserted out of the blister package	Device: Day Acuvue Moist or Focus DAILIES with AquaRelease Daily Disposable Lenses Lenses inserted out of the blister package

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No requirement as to subject sex, race, occupation or reason for wearing contact lenses.
Subjects visual acuity must be correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses to enter the study
Subjects must be successfully wearing hydrogel or silicone hydrogel contact lenses prior to study

Exclusion Criteria:

History of hypersensitivity to any components of the solution
Evidence or history of keratitis
One functional eye or a monofit lens
Active acute blepharitis, corneal infections or iritis.
Any abnormal slit-lamp finding at visit 1 of each study period.
Significant corneal staining at visit 1 of each study period.

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 ( Renee Garofalo )
Study ID Numbers:	MS-008
Study First Received:	August 11, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00733291 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Daily disposable contact lenses
multi-purpose solutions

ClinicalTrials.gov processed this record on August 26, 2009