Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

NCT01016652 | Completed Results

• 2 other identifiers: CR-4558VMFL-511
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ

  week 4

• Subject Reported Lens Comfort Using CLUE Questionnaire

  week 4

• Comfortable Wearing Time

  week 4

• Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper

  Baseline

Study Arms (2)

etafilcon A multifocal / etafilcon A sphere

OTHER

period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.

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

etafilcon A sphere / etafilcon A multifocal

OTHER

period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.

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

Interventions

etafilcon A multifocal contact lens DEVICE

low-add multifocal contact lens

etafilcon A multifocal / etafilcon A sphere; etafilcon A sphere / etafilcon A multifocal

etafilcon A Contact Lens DEVICE

standard sphere contact lens

etafilcon A multifocal / etafilcon A sphere; etafilcon A sphere / etafilcon A multifocal

Eligibility Criteria

• Age: 35 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (8)

Unknown Facility

North Little Rock, Arkansas, United States

Location

Unknown Facility

Blue Springs, Missouri, United States

Location

Unknown Facility

Lake Ozark, Missouri, United States

Location

Unknown Facility

Warren, Ohio, United States

Location

Unknown Facility

Kittanning, Pennsylvania, United States

Location

Unknown Facility

Warwick, Rhode Island, United States

Location

Unknown Facility

Chamberlain, South Dakota, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Thomas R. Karkkainen OD, MS, FAAO Senior Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care

TKarkkai@its.jnj.com

(904)443-3402

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 19, 2018
• Results First Posted: January 23, 2014

Record last verified: 2017-08

Locations

US (8)