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OpenTrials
Completed

NCT Number: NCT01016652

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

35 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etafilcon A multifocal contact lens

Device

low-add multifocal contact lens

Etafilcon A contact lens

Device

standard sphere contact lens

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: week 4

    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).

  2. Subject Reported Lens Comfort Using CLUE Questionnaire

    Time frame: week 4

    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.

  3. Comfortable Wearing Time

    Time frame: week 4

    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.

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

    Time frame: Baseline

    Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Visioncare Research Ltd.

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2009
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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