Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

Study Overview
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Brief Summary
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The objective of this study is to evaluate the performance of a novel multifocal lens system.

Conditions
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Presbyopia

Intervention / Treatment
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* Device: etafilcon A
* Device: lotrafilcon B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol. Subjects must be between 40 and 70 years of age. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye. Subjects' should own a wearable pair of spectacles. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration). Subjects' must respond positively to at least on symptom on the Presbyopis Symptoms Questionnaire or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.). Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.) Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. History of binocular vision abnormality or strabismus. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV). History of diabetes. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etafilcon A/lotrafilcon B<br>Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens. | Device: etafilcon A<br>* To be worn in a daily wear modality for a minimum of 6 hours per day.<br>Device: lotrafilcon B<br>* Lenses will be worn in a reuseable modality; cleaned and disinfected each night.<br>* Other names: AirOptix Aqua Multifocal;|
| Active Comparator: lotrafilcon B/etafilcon A<br>Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens. | Device: etafilcon A<br>* To be worn in a daily wear modality for a minimum of 6 hours per day.<br>Device: lotrafilcon B<br>* Lenses will be worn in a reuseable modality; cleaned and disinfected each night.<br>* Other names: AirOptix Aqua Multifocal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Distance Visual Acuity (LogMAR) | Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%) | 8-12 days post wear | 
| Binocular Near Visual Acuity (logMAR) | Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%). | 8-12 days post wear | 
| Percentage of Eyes With Corneal Staining Grade 3 or Higher | Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions. | 8-12 days post wear | 
| Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher | The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions. | 8-12 days post wear | 
| Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher | Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions. | 8-12 days post wear | 
| CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire | CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. 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). | 8-12 days post wear |