- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595502
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses
June 13, 2017 updated by: Johnson & Johnson Vision Care, Inc.
The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
286
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
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Alabama
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Montgomery, Alabama, United States, 36117
- Becky Bizzle, OD
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Florida
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Fruit Cove, Florida, United States, 32259
- Complete Family Eye Care of Fruit Cove
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Sarasota, Florida, United States, 34232
- Golden Family Eyecare
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Tampa, Florida, United States, 33625
- St. Lucy's Vision Center
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Winter Park, Florida, United States, 32792
- Eye Associates of Winter Park
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Georgia
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Roswell, Georgia, United States, 30076
- VisualEyes, Inc.
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Kansas
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Neodesha, Kansas, United States, 66757
- Advantage Eyecare Associates, LLC
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New York
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Vestal, New York, United States, 13850
- Sacco Eye Group
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North Carolina
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Denver, North Carolina, United States, 28037
- Advanced Family Eye Care
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Tennessee
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Memphis, Tennessee, United States, 38119
- Total Eye Care PA
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Texas
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Jacksonville, Texas, United States, 17576
- Brian Frazier, OD
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Virginia
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Roanoke, Virginia, United States, 24153
- Timothy R. Poling, OD
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Wisconsin
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West Allis, Wisconsin, United States, 53227
- Ziegler Leffingwell Eyecare
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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 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
- The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.
- The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of medication, which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision, multi-focal, toric, or extended wear contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
- Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) 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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sequence 1: Test Control Test
Test/control/test using the Johnson & Johnson Vision Care (JJVC) Marketed contact lens (test) and the Competitor Marketed contact lens (control).
Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each in between lenses for total study duration of approximately three weeks per subject.
Subjects are required to wear the lenses at least five days for at least eight hours per day worn.
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Other Names:
Other Names:
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Active Comparator: Sequence 2: Control Test Control
Control/test/control using the JJVC Marketed contact lens (test) and the Competitor Marketed contact lens (control).
Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each for total study duration of approximately three weeks per subject.
Subjects are required to wear the lenses at least five days for at least eight hours per day worn.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Comfort
Time Frame: 1 Week
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Overall comfort 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.
Please note this was a 2 treatment by 3 period study design.
Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type.
For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively.
For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.
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1 Week
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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)
September 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
November 2, 2015
First Submitted That Met QC Criteria
November 2, 2015
First Posted (Estimate)
November 3, 2015
Study Record Updates
Last Update Posted (Actual)
July 5, 2017
Last Update Submitted That Met QC Criteria
June 13, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-5743
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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