Clinical Evaluation of Multifocal Toric Contact Lenses
August 24, 2020 updated by: Johnson & Johnson Vision Care, Inc.
This is a double-masked, bilateral, randomized, non-dispensing clinical trial.
The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods.
The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair.
Two lens types will be fit at the first visit and three lens types will be fit at the second visit.
Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types.
Randomization will be stratified by site.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Device: etafilcon A Investigational Toric Multifocal Contact Lens
- Device: etafilcon A Investigational Toric Multifocal Contact Lens
- Device: etafilcon A Investigational Toric Multifocal Contact Lens
- Device: etafilcon A Investigational Toric Multifocal Contact Lens
- Device: etafilcon A Investigational Toric Multifocal Contact Lens
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Whittier, California, United States, 90606
- Golden Optometric Group
-
-
Florida
-
Orlando, Florida, United States, 32819
- Bay Hill Eye Care
-
-
Hawaii
-
Kahului, Hawaii, United States, 96732
- Lee & Leong Doctors of Optometry
-
-
New York
-
Jamestown, New York, United States, 14750
- Spectrum Eyecare
-
Vestal, New York, United States, 13850
- Sacco Eye Group
-
-
Ohio
-
Miamisburg, Ohio, United States, 45342
- Miamisburg Vision Care
-
-
Tennessee
-
Memphis, Tennessee, United States, 38111
- Optometry Group, PLLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- The subject must be between 40 and 70 years of age.
- The subject's distance refraction must be in the range of -1.50 D to -4.50 D.
- The subject's refractive cylinder must be -1.00 to -1.50 D in each eye
- The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye
- Subjects must own a wearable pair of spectacles if required for their distance vision
- The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration)
- The subject must already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the "Presbyopic Systems Questionnaire".
Exclusion Criteria:
- Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear
- Pregnancy or lactation
- Currently diagnosed with diabetes
- Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, HIV).
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear
- Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions
- Any previous, or planned, ocular or intraocular surgery (eg, radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc)
- A history of amblyopia, strabismus or binocular vision abnormality
- Any ocular infection or inflammation
- Any ocular abnormality that may interfere with contact lens wear
- Use of any ocular medication, with the exception of rewetting drops
- History of herpetic keratitis
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
- Employee of clinical site (eg, Investigator, Coordinator, Technician).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence 1
etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 2
etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 3
etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 4
etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 5
etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 6
etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 7
etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 8
etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 9
etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
|
Experimental: Sequence 10
etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator)
|
Test Lens 1
Test Lens 2
Tes Lens 3
Test Lens 4
Control Lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Handling Comparison Between Test 1/Test 2 and Control
Time Frame: 15 minutes
|
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire.
CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Handling Comparison Between Test 3/Test 4 and Control
Time Frame: 15 minutes
|
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire.
CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2017
Primary Completion (Actual)
July 21, 2017
Study Completion (Actual)
July 21, 2017
Study Registration Dates
First Submitted
June 30, 2017
First Submitted That Met QC Criteria
June 30, 2017
First Posted (Actual)
July 5, 2017
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- CR-5935
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Visual Acuity
-
Mayo ClinicNot yet recruitingVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.Completed
-
Alcon ResearchQueensland University of TechnologyCompleted
-
Alcon ResearchCompletedVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
Clinical Trials on etafilcon A Investigational Toric Multifocal Contact Lens
-
Johnson & Johnson Vision Care, Inc.Visioncare Research Ltd.Completed
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedAstigmatismUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States
-
University of HoustonCompleted
-
Johnson & Johnson Vision Care, Inc.CompletedVision CorrectionUnited States, United Kingdom
-
Johnson & Johnson Vision Care, Inc.Foresight Regulatory Strategies, Inc.Completed
-
CooperVision, Inc.CompletedPresbyopia | AstigmatismUnited Kingdom
-
CIBA VISIONCompletedPresbyopia | Myopia