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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

November 18, 2009
January 22, 2014
October 2009
December 2009   (final data collection date for primary outcome measure)
  • 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.
Subjective Vision [ Time Frame: After two weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01016652 on ClinicalTrials.gov Archive Site
  • 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
Amplitude of Accommodation [ Time Frame: After two weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Presbyopia
  • Device: etafilcon A multifocal contact lens
    low-add multifocal contact lens
  • Device: etafilcon A Contact Lens
    standard sphere contact lens
  • etafilcon A multifocal / etafilcon A sphere
    period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.
    Interventions:
    • Device: etafilcon A multifocal contact lens
    • Device: etafilcon A Contact Lens
  • etafilcon A sphere / etafilcon A multifocal
    period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.
    Interventions:
    • Device: etafilcon A multifocal contact lens
    • Device: etafilcon A Contact Lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
Not Provided
December 2009   (final data collection date for primary outcome measure)

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.
Both
35 Years to 47 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016652
CR-4558, VMFL-511
No
Vistakon
Vistakon
Visioncare Research Ltd.
Not Provided
Vistakon
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP