Evaluation of an Investigational Multifocal Lens

Study Overview
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Brief Summary
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The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Conditions
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Presbyopia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects were required to have read, understand, and signed 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 instructions set forth in this clinical protocol. Between 40 and 70 years of age. Subjects must own a wearable pair of spectacles, if required for their distance vision. 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 of more duration) Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire* The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye. Refractive cylinder ≤ -0.75 D in each eye. ADD power in the range +0.75 D to +2.50 D in each eye. Best corrected visual acuity of 20/20-3 or better in each eye. Exclusion Criteria: Currently pregnant or lactating (subjects who became pregnant during the study were discontinued). Any ocular or systemic allergies that may have contraindicated contact lens wear. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear. Any ocular abnormality that may have interfered with contact lens wear. Use of any ocular medication, with the exception of rewetting drops. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). History of herpetic keratitis. History of binocular vision abnormality or strabismus. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV). History of diabetes. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 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 or inflammation. Any corneal distortion or irregular cornea.

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: lotrafilcon B / etafilcon A<br>Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens. | Device: lotrafilcon B<br>* Soft contact lens to be worn as daily wear, monthly replacement modality.<br>* Other names: AirOptix Aqua Multifocal;Device: etafilcon A<br>* Soft contact lens to be worn as daily wear, daily disposable modality.<br>|
| Experimental: etafilcon A / lotrafilcon B<br>Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens. | Device: lotrafilcon B<br>* Soft contact lens to be worn as daily wear, monthly replacement modality.<br>* Other names: AirOptix Aqua Multifocal;Device: etafilcon A<br>* Soft contact lens to be worn as daily wear, daily disposable modality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Distance Binocular Visual Acuity (LogMAR) | Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast. | 8- 12 Days post wear | 
| Intermediate Binocular Visual Acuity (LogMAR) | Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast. | 8-12 days post wear | 
| Near Binocular Visual Acuity (LogMAR) | Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast. | 8-12 days post wear | 
| Corneal Staining | Corneal staining is evaluated 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 staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. | 8 - 12 Days post wear | 
| Bulbar Conjunctival Injection | The bulbar is the scelra. Bulbar Conjunctival Injection was assessed 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. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. | 8- 12 Days post wear | 
| Limbal Conjunctival Injection | The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed 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 Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. | 8- 12 Days post wear | 
| Contact Lens Fitting | Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported. | 8- 12 Days post wear |