Adults 35 to 47, any sex, with Presbyopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subject Reported Overall Vision Quality Using (CLUE)TM QuestionnairePrimary· 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.
Group
Value
95% CI
Etafilcon A Multifocal
41.0
30.0 – 51.0
Etafilcon A Sphere
39.0
28.0 – 50.0
Monocular Amplitude of AccommodationPrimary· 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.
Group
Value
95% CI
Etafilcon A Multifocal
0.00
-0.075 – 0.025
Etafilcon A Sphere
0.00
-0.075 – 0.01
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQSecondary· 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).
Group
Value
95% CI
Etafilcon A Multifocal
53
Etafilcon A Sphere
43
Subject Reported Lens Comfort Using CLUE QuestionnaireSecondary· 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.
Group
Value
95% CI
Etafilcon A Multifocal
59.0
38.0 – 75.0
Etafilcon A Sphere
59.0
50.0 – 77.0
Comfortable Wearing TimeSecondary· 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.
Group
Value
95% CI
Etafilcon A Multifocal
14
11 – 15
Etafilcon A Sphere
14
12 – 14.5
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative FlipperSecondary· Baseline
Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects
Group
Value
95% CI
Etafilcon A Multifocal
52
Etafilcon A Sphere
58
Sponsor's own description
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 19 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01016652.