Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).

Official Title
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Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions

Conditions
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Contact Lens Solutions

Intervention / Treatment
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* Other: Solution 1 (Test)
* Other: Solution 2 (Test)
* Other: Solution 3 (Test)
* Other: Solution 4 (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol. The subject must be between 18 and 69 years of age. The subject must be willing to participate in a 9-month study. The subject must require a visual correction in both eyes. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye. The subject must have best-corrected visual acuity of 0.20 or better in each eye. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear. Exclusion Criteria: Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued). Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.). Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear. Any active ocular infection. Current use of topical ophthalmic medications. History of binocular vision abnormality or strabismus. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average). Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report. History of severe allergic reaction or anaphylaxis. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear. Employee of the investigational clinic (e.g. investigator, coordinator, technician) They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lens A (senofilcon A)<br>Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). | Other: Solution 1 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order<br>* Other names: Revitalens;Other: Solution 2 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Pure Moist;Other: Solution 3 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Biotrue;Other: Solution 4 (Control)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Clear Care;|
| Other: Lens B (galyfilcon A)<br>Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). | Other: Solution 1 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order<br>* Other names: Revitalens;Other: Solution 2 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Pure Moist;Other: Solution 3 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Biotrue;Other: Solution 4 (Control)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Clear Care;|
| Other: Lens C (etafilcon A)<br>Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)). | Other: Solution 1 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order<br>* Other names: Revitalens;Other: Solution 2 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Pure Moist;Other: Solution 3 (Test)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Biotrue;Other: Solution 4 (Control)<br>* Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order<br>* Other names: Clear Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort Score (Senofilcon A Lens) | CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | 2-Week Follow-up | 
| Overall Comfort Score (Galyfilcon A Lens) | CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | 2-Week Follow-up | 
| Overall Comfort Score (Etafilcon A Lens) | CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | 2-Week Follow-up |