Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 8
- Primary Endpoint
- Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
Study Overview
Brief Summary
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 47 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
etafilcon A multifocal / etafilcon A sphere
period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.
Intervention: etafilcon A multifocal contact lens (Device)
etafilcon A multifocal / etafilcon A sphere
period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.
Intervention: etafilcon A Contact Lens (Device)
etafilcon A sphere / etafilcon A multifocal
period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.
Intervention: etafilcon A multifocal contact lens (Device)
etafilcon A sphere / etafilcon A multifocal
period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.
Intervention: etafilcon A Contact Lens (Device)
Outcomes
Primary Outcomes
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
Time Frame: 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
Time Frame: 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 Outcomes
- Comfortable Wearing Time(week 4)
- Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ(week 4)
- Subject Reported Lens Comfort Using CLUE Questionnaire(week 4)
- Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper(Baseline)