Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Not Applicable

Completed

Interventions: Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
Drug: Alcon Opti-Free® RepleniSH®
Drug: B&L ReNu MultiPlus™

Brief Summary: The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Detailed Description: The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Recruitment & Eligibility

Inclusion Criteria

Is at least 17 years of age and has full legal capacity to volunteer.
Has read, understood and signed an information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
Has clear corneas and no active ocular disease.
Has had an ocular examination in the last two years.
Is a current soft lens wearer, replacing their lenses every two weeks to one month.
Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria

Has any signs or symptoms of dry eye.
Has any clinically significant blepharitis.
Has undergone corneal refractive surgery.
Is aphakic.
Has any active ocular disease.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that may affect ocular health.
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Is pregnant or lactating.
Is participating in any other type of clinical or research study.
Currently wears daily disposable lenses.
Currently wears lenses on an extended wear basis.

Arm && Interventions

Group	Intervention	Description
Phase1 - Arm 1	Alcon Opti-Free® RepleniSH® with Supraclens®	-
Phase 2 - Arm 1	Alcon Opti-Free® RepleniSH® with Supraclens®	-
Phase1 - Arm 1	Alcon Opti-Free® RepleniSH®	-
Phase1 - Arm 2	Alcon Opti-Free® RepleniSH® with Supraclens®	-
Phase 2 - Arm 2	B&L ReNu MultiPlus™	-
Phase1 - Arm 2	Alcon Opti-Free® RepleniSH®	-
Phase 2 - Arm 1	B&L ReNu MultiPlus™	-
Phase 2 - Arm 2	Alcon Opti-Free® RepleniSH® with Supraclens®	-

Primary Outcome Measures

Name	Time	Method
Lens Deposits	4 weeks	Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
Comfort	4 weeks	Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Lens Wettability	4 weeks	Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).

Secondary Outcome Measures

Name	Time	Method
Subjective Vision	4 weeks	Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
Dryness	4 weeks	Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
Corneal Staining	4 weeks	Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.