Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
October 1, 2019 updated by: Johnson & Johnson Vision Care, Inc.
This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.
Study Overview
Status
Completed
Intervention / Treatment
- Device: Opti-Free : RevitaLens / Clear Care : RevitaLens
- Device: Opti-Free : RevitaLens / RevitaLens : Clear Care
- Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens
- Device: Clear Care : RevitaLens / RevitaLens : Opti-Free
- Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens
- Device: RevitaLens : Clear Care / RevitaLens : Opti-Free
- Device: RevitaLens : Opti-Free / Clear Care : RevitaLens
- Device: RevitaLens : Opit-Free / RevitaLens : Clear Care
Study Type
Interventional
Enrollment (Actual)
130
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
-
Anaheim, California, United States, 92807
- Southern California College of Optometry
-
Berkeley, California, United States, 94720
- University of California, Berkeley School of Optometry
-
-
Florida
-
Jacksonville, Florida, United States, 32205
- Vue Optical Boutique
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Texas
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Houston, Texas, United States, 77240
- University of Houston College of Optometry
-
-
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
18 years to 69 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:
- Subjects must be 18-69 years of age (inclusive).
- Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
- Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
- The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
- The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
- Subjects must read, understand, and sign the Statement of Informed Consent.
Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or breast-feeding.
- Diabetes
- Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
- Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
- Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
- Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
- Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
- Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
- Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
- History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
- Habitual contact lens wear modality as extended wear.
- Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Habitual wearers of rigid gas permeable lens within the past 3 months.
- Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: etafilcon A
Eligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study.
|
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
|
|
ACTIVE_COMPARATOR: senofilcon A
Eligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study.
|
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
|
|
ACTIVE_COMPARATOR: senofilcon C
Eligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study.
|
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses.
Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subject Comfort
Time Frame: Up to 2-Hours Post Lens Fitting
|
Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort.
VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable).
VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit.
The average comfort score for each solution was reported.
This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.
|
Up to 2-Hours Post Lens Fitting
|
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)
February 7, 2018
Primary Completion (ACTUAL)
June 19, 2018
Study Completion (ACTUAL)
June 19, 2018
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
March 8, 2018
First Posted (ACTUAL)
March 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 2, 2019
Last Update Submitted That Met QC Criteria
October 1, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CR-6012
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.
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