- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02625233
Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses
May 19, 2017 updated by: Johnson & Johnson Vision Care, Inc.
This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control).
Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
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
-
-
Florida
-
Jacksonville, Florida, United States, 32205
- Vue Optical Boutique
-
Longwood, Florida, United States, 32779
- Omega Vision Center, PA / Sabal Eye Care
-
-
Illinois
-
Bloomington, Illinois, United States, 61701
- Eyecare Associates
-
-
New Jersey
-
Closter, New Jersey, United States, 07624
- Dr. Debbie H. Kim, OD
-
-
New York
-
Vestal, New York, United States, 13850
- Sacco Eye Group
-
-
Utah
-
Salt Lake City, Utah, United States, 84106
- Dr. William Bogus
-
-
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 and older (Adult, Older 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 at least 18 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
- The subject's refractive cylinder must be ≤ 1.00 Diopters (D) in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- The subject should own a wearable pair of spectacles and bring to initial visit.
- The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- The subject must have enrolled and completed all visits in clinical study (NCT02515994).
Exclusion Criteria:
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
- Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g., Accutane), oral tetracyclines, topical scopolamine, oral phenothiazines (e.g. Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or OTC ocular medication.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- 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 known hypersensitivity or allergic reaction to Opti-Free® PureMoist® multipurpose care solution or Eye-Cept rewetting drop solution
- Any ocular infection, allergy or clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Daily disposables, extended wear, monovision or multi-focal contact lens correction.
- History of binocular vision abnormality or strabismus.
- Employee or relative of employees of sponsor or investigational clinic (e.g., 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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: senofilcon C
Vistakon Investigational Contact Lens (Test)
|
|
Active Comparator: comfilcon A
Marketed Monthly Wear Contact Lens (Control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Eyes Grade 3 or Higher SLF
Time Frame: Up to 6 Month Follow-up
|
Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced.
Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations.
This study is a continuation of a previous study therefore data from the initial visit was included in reporting.
The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.
|
Up to 6 Month Follow-up
|
Visual Acuity (logMAR)
Time Frame: Up to 6 Month Follow-up
|
The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations.
This study is a continuation of a previous study therefore data from the initial visit was included in reporting.
The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.
|
Up to 6 Month Follow-up
|
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)
October 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
November 3, 2015
First Submitted That Met QC Criteria
December 4, 2015
First Posted (Estimate)
December 9, 2015
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-5788
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 Disorders
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; University Ghent; Research Foundation Flanders; Free University of Brussels and other collaboratorsUnknowniVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment (iVision)Visual Perceptual Weakness (Disorder) | Cerebral Visual ImpairmentBelgium
-
Nantes University HospitalCompletedVisual DisordersFrance
-
University Health Network, TorontoNot yet recruitingStroke | Cognitive Impairment | Virtual Reality | Visual Impairment | Low Vision | Driving Impaired | Visual Spatial Processing | Visual Processing Speed | Visual Field DefectCanada
-
Beth Israel Deaconess Medical CenterRecruitingStroke | Visual Impairment | Visual Field Defect, Peripheral | Visual Field Defect Homonymous Bilateral | Hemianopsia | Quadrantanopia | Cortical Blindness | Occipital Lobe Infarct | Visual Fields HemianopsiaUnited States
-
Stanford UniversityNational Eye Institute (NEI)Enrolling by invitationRepetitive Transcranial Magnetic Stimulation | Visual Attention | Visual Cortical PlasticityUnited States
-
Universitaire Ziekenhuizen KU LeuvenVrije Universiteit Brussel; Fund for Scientific Research, Flanders, BelgiumRecruitingCerebral Visual ImpairmentBelgium
-
Brigham and Women's HospitalRecruitingIncidental Findings | Visual Attention | Visual Search | Hybrid SearchUnited States
-
Weill Medical College of Cornell UniversityCompletedIntraocular Pressure | Visual Acuity | Visual DisturbanceUnited States
-
University of MiamiCompletedVisual Field Defect, Peripheral | Visual Field Defect, Nasal Step | Visual Field Defect, Paracentral Scotoma of Both EyesUnited States
-
Russell L. WoodsResearch to Prevent Blindness / Lions Club International FoundationNot yet recruitingCentral Visual Impairment
Clinical Trials on comfilcon A
-
Coopervision, Inc.CompletedPresbyopiaUnited States
-
Coopervision, Inc.CompletedPresbyopiaUnited States
-
Coopervision, Inc.Completed
-
Coopervision, Inc.CompletedAstigmatism | MyopiaUnited States
-
Johnson & Johnson Vision Care, Inc.Visioncare Research Ltd.; Foresight Regulatory Strategies, Inc.CompletedRefractive Error
-
Coopervision, Inc.CompletedMyopiaUnited States, United Kingdom