BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens

Study Overview
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Brief Summary
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To determine if patients are unreactive to the lens care solution / Biofinity combination.

Detailed Description
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To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.

Official Title
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BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study

Conditions
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Myopia

Intervention / Treatment
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* Other: Bioclean First Care EX / comfilcon A
* Other: Aosept Clearcare / comfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is over 18 years of age (inclusive) Has had a self-reported visual exam in the last two years Is currently an adapted spherical soft CL wearer Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive) Has less than 1.00D spectacle cylinder in each eye. Is correctable to a visual acuity of 20/20 or better in both eyes Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Is willing to comply with the wear schedule (at least 40 hrs per week) Is willing to comply with the visit schedule Exclusion Criteria: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a CL prescription outside the range of - 0.25 to -12.00D Has a spectacle cylinder greater than -0.75D of cylinder in either eye. Has best corrected spectacle distance vision worse than 20/20 in either eye. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion Has persistent, clinically significant corneal or conjunctival staining Has active neovascularization or any central corneal scars. Is aphakic. Is pregnant or lactating. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bioclean First Care EX combo, then Aosept Clearcare combo<br>Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination. | Other: Bioclean First Care EX / comfilcon A<br>* Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.<br>Other: Aosept Clearcare / comfilcon A<br>* Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.<br>|
| Active Comparator: Aosept Clearcare combo, then Bioclean First Care EX combo<br>Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination. | Other: Bioclean First Care EX / comfilcon A<br>* Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.<br>Other: Aosept Clearcare / comfilcon A<br>* Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Health - Corneal Staining | Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). | 1 week | 
| Ocular Health - Conjunctival Redness | Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). | 1 week | 
| Ocular Health - Limbal Redness | Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). | 1 week | 
| Ocular Health - Papillary Conjunctivitis | Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stinging Sensation Right After Insertion (Subjective Rating) | Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all). | Baseline | 
| Burning Sensation Right After Insertion (Subjective Rating) | Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all). | Baseline |