Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: etafilcon A multifocal contact lens; Device: etafilcon A Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States
  • Missouri
    • Blue Springs, Missouri, United States
    • Lake Ozark, Missouri, United States
  • Ohio
    • Warren, Ohio, United States
  • Pennsylvania
    • Kittanning, Pennsylvania, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Dakota
    • Chamberlain, South Dakota, United States
  • Vermont
    • Burlington, Vermont, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 18, 2009
• First Posted (Estimate): November 19, 2009

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CR-4558; VMFL-511 (Other Identifier: Visioncare Research, Ltd.)