Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Not Applicable

Completed

Interventions: Device: etafilcon A multifocal contact lens
Device: etafilcon A Contact Lens

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

Recruitment & Eligibility

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:
1. No amblyopia.
2. No evidence of lid abnormality or infection.
3. No conjunctival abnormality or infection.
4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
5. 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.

Arm && Interventions

Group	Intervention	Description
etafilcon A sphere / etafilcon A multifocal	etafilcon A Contact Lens	period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.
etafilcon A multifocal / etafilcon A sphere	etafilcon A Contact Lens	period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.
etafilcon A sphere / etafilcon A multifocal	etafilcon A multifocal contact lens	period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.
etafilcon A multifocal / etafilcon A sphere	etafilcon A multifocal contact lens	period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.

Primary Outcome Measures

Name	Time	Method
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire	week 4	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.
Monocular Amplitude of Accommodation	week 4	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.

Secondary Outcome Measures

Name	Time	Method
Comfortable Wearing Time	week 4	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.
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ	week 4	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).
Subject Reported Lens Comfort Using CLUE Questionnaire	week 4	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.
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper	Baseline	Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects