Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.

Conditions
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Presbyopia

Intervention / Treatment
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* Device: etafilcon A multifocal contact lens
* Device: etafilcon A Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]). Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). Between 35 and 47 years of age (inclusive). Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes. Refractive astigmatism of 0.75D or less in both eyes. Visual symptoms associated with near vision Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: No amblyopia. No evidence of lid abnormality or infection. No conjunctival abnormality or infection. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities). No other active ocular disease. Exclusion Criteria: Monovision user or multifocal CL wearer. Regular user of reading spectacles (i.e. daily usage). Requires concurrent ocular medication. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear. Corneal staining Grade 3 in more than two regions. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study. Pre-existing ocular irritation that would preclude CL fitting. Keratoconus or other corneal irregularity.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 47 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: etafilcon A multifocal / etafilcon A sphere<br>period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn. | Device: etafilcon A multifocal contact lens<br>* low-add multifocal contact lens<br>Device: etafilcon A Contact Lens<br>* standard sphere contact lens<br>|
| Other: etafilcon A sphere / etafilcon A multifocal<br>period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn. | Device: etafilcon A multifocal contact lens<br>* low-add multifocal contact lens<br>Device: etafilcon A Contact Lens<br>* standard sphere contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire | The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with scores ranging from 0-120. | week 4 | 
| Monocular Amplitude of Accommodation | The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated. | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ | Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly). | week 4 | 
| Subject Reported Lens Comfort Using CLUE Questionnaire | Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. Scores range from 0 -120. | week 4 | 
| Comfortable Wearing Time | Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable. | week 4 | 
| Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper | Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects | Baseline |