Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

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• Presbyopia 324

Presbyopia

324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.

This study's enrollment of 49 is below the median of 61 across 265 interventional studies indexed under Presbyopia.

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Study arms

• 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 · Device: etafilcon A 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 · Device: etafilcon A Contact Lens

Interventions

• Deviceetafilcon A multifocal contact lens

  low-add multifocal contact lens

• Deviceetafilcon A Contact Lens

  standard sphere contact lens

Primary outcomes

1. 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.

   Time frame: week 4

2. 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.

   Time frame: week 4

Secondary outcomes

1. 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).

   Time frame: week 4

2. 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.

   Time frame: week 4

3. 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.

   Time frame: week 4

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

   Time frame: Baseline

Baseline characteristics