Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01016652
First received: November 18, 2009
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Presbyopia
Device: etafilcon A multifocal contact lens
Device: etafilcon A Contact Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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.

  • Comfortable Wearing Time [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 Benefiting From the Binocular +/-1.00D Accommodative Flipper [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects


Enrollment: 49
Study Start Date: October 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   35 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016652

Locations
United States, Arkansas
North Little Rock, Arkansas, United States
United States, Missouri
Blue Springs, Missouri, United States
Lake Ozark, Missouri, United States
United States, Ohio
Warren, Ohio, United States
United States, Pennsylvania
Kittanning, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Dakota
Chamberlain, South Dakota, United States
United States, Vermont
Burlington, Vermont, United States
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01016652     History of Changes
Other Study ID Numbers: CR-4558, VMFL-511
Study First Received: November 18, 2009
Results First Received: September 19, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014