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NCT03150485

Clinical Evaluation of Fitting Investigational Contact Lenses

Completed NA Results posted Last updated 29 June 2018
What this trial tests

NA trial testing JJVC Fitting Guides in Visual Acuity in 23 participants. Completed in 31 March 2017.

Timeline
27 March 2017
Primary endpoint
31 March 2017
31 March 2017

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment23
Start date27 March 2017
Primary completion31 March 2017
Estimated completion31 March 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 40 to 70, any sex, with Visual Acuity. 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.

The Average Number of Fitting Modifications to Optimize Vision Primary · 15 minutes post lens insertion

The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported.

GroupValue95% CI
JJVC Fitting Guides0.30± 0.553
Subject's Responses to Individual Item 1 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?". This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported.

Extremely Satisfied
GroupValue95% CI
JJVC Fitting Guides63.6
Very Satisfied
GroupValue95% CI
JJVC Fitting Guides31.8
Moderately Satisfied
GroupValue95% CI
JJVC Fitting Guides4.6
Slightly Satisfied
GroupValue95% CI
JJVC Fitting Guides0
Not at all Satisfied
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 2 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?". This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported.

Extremely likely
GroupValue95% CI
JJVC Fitting Guides59.1
Very likely
GroupValue95% CI
JJVC Fitting Guides36.4
Somewhat likely
GroupValue95% CI
JJVC Fitting Guides4.6
Slightly likely
GroupValue95% CI
JJVC Fitting Guides0
Not at all likely
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 3 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?". This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported.

Very Satisfied
GroupValue95% CI
JJVC Fitting Guides86.4
Satisfied
GroupValue95% CI
JJVC Fitting Guides13.6
Unsure
GroupValue95% CI
JJVC Fitting Guides0
Dissatisfied
GroupValue95% CI
JJVC Fitting Guides0
Very Dissatisfied
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 4 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.". The percentage of subject's in each response category was reported.

On a website for particular brand of contacts
GroupValue95% CI
JJVC Fitting Guides63.3
On a general healthcare website such as WebMD
GroupValue95% CI
JJVC Fitting Guides9.1
In a Magazine
GroupValue95% CI
JJVC Fitting Guides22.7
In a Newspaper
GroupValue95% CI
JJVC Fitting Guides4.6
On a search engine (ex: Google)
GroupValue95% CI
JJVC Fitting Guides45.5
On a Blog
GroupValue95% CI
JJVC Fitting Guides0
On Social Media Networks
GroupValue95% CI
JJVC Fitting Guides9.1
On YouTube
GroupValue95% CI
JJVC Fitting Guides9.1
Subject's Responses to Individual Item 5 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?". This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported.

All of the time
GroupValue95% CI
JJVC Fitting Guides86.4
Usually
GroupValue95% CI
JJVC Fitting Guides13.6
Frequently
GroupValue95% CI
JJVC Fitting Guides0
Sometimes
GroupValue95% CI
JJVC Fitting Guides0
Rarely
GroupValue95% CI
JJVC Fitting Guides0
Never
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 6 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "What Are Your Current Vision Correction Solutions?". The percentage of subject's in each response category was reported.

Toric Contact lenses
GroupValue95% CI
JJVC Fitting Guides27.3
Multifocal Contact lenses
GroupValue95% CI
JJVC Fitting Guides40.9
Monovision
GroupValue95% CI
JJVC Fitting Guides36.4
Readers
GroupValue95% CI
JJVC Fitting Guides36.4
Progressive lenses
GroupValue95% CI
JJVC Fitting Guides9.1
Other
GroupValue95% CI
JJVC Fitting Guides13.6
Subject's Responses to Individual Item 7 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?". This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported.

Much Better
GroupValue95% CI
JJVC Fitting Guides50.0
Somewhat Better
GroupValue95% CI
JJVC Fitting Guides31.8
About the Same
GroupValue95% CI
JJVC Fitting Guides13.6
Somewhat Worse
GroupValue95% CI
JJVC Fitting Guides4.6
Much Worse
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 8 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?". This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported.

Very Excited
GroupValue95% CI
JJVC Fitting Guides59.1
Excited
GroupValue95% CI
JJVC Fitting Guides27.3
Unsure
GroupValue95% CI
JJVC Fitting Guides13.6
Unexcited
GroupValue95% CI
JJVC Fitting Guides0
Very Unexcited
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 9 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.

Excellent
GroupValue95% CI
JJVC Fitting Guides63.6
Very Good
GroupValue95% CI
JJVC Fitting Guides31.8
Good
GroupValue95% CI
JJVC Fitting Guides4.6
Fair
GroupValue95% CI
JJVC Fitting Guides0
Poor
GroupValue95% CI
JJVC Fitting Guides0
Subject's Responses to Individual Item 10 Secondary · 15 Minuted Post Lens Insertion

Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.

Excellent
GroupValue95% CI
JJVC Fitting Guides77.3
Very Good
GroupValue95% CI
JJVC Fitting Guides18.2
Good
GroupValue95% CI
JJVC Fitting Guides4.6
Fair
GroupValue95% CI
JJVC Fitting Guides0
Poor
GroupValue95% CI
JJVC Fitting Guides0

Sponsor's own description

This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of JJVC Fitting Guides

Trials testing the same drug.

Other recruiting trials for Visual Acuity

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03150485.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing