- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02310126
Handling Comparison Between Two Contact Lens Types
June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
Subjects will evaluate each study lens in a random order.
The lenses will be worn in both eyes for a short period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
195
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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Florida
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Jacksonville, Florida, United States, 32256
- Baymeadows Vision Center
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Jacksonville, Florida, United States, 32256
- Eye Elements Eyecare
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Jacksonville, Florida, United States, 32256
- Vistakon Research Clinic
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Sarasota, Florida, United States, 34232
- Golden Family Eyecare
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Winter Park, Florida, United States, 32792
- Eye Associates of Winter Park
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Ohio
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Columbus, Ohio, United States, 43202
- Central Ohio Eyecare
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Tennessee
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Memphis, Tennessee, United States, 38111
- Optometry Group LLC
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Nashville, Tennessee, United States, 37205
- Nashville Vision Associates
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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
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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 40 and 70 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
- The subject's refractive cylinder must be less than or equal to -0.75 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 best corrected visual acuity of 20/20 -3 or better in each eye.
- Subject must own a wearable pair of spectacles.
- The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
- The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
Exclusion Criteria:
- Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- Any ocular infection or inflammation.
- History of herpetic keratitis.
- Any corneal distortion or irregular cornea.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
- Current history of diabetes.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: etafilcon A(sphere)/etafilcon A(multi-focal)
Subjects were randomized to one of two lens wear sequences.
subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.
|
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Names:
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Names:
|
Active Comparator: etafilcon A(multi-focal)/etafilcon A(sphere)
Subjects were randomized to one of two lens wear sequences.
subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.
|
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Names:
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
Time Frame: 15 minutes post Contact Lens Insertion
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CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire.
CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
97% of the scores fall within 0 and 120 (mean +/-3XSD).
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15 minutes post Contact Lens Insertion
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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)
November 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 3, 2014
First Submitted That Met QC Criteria
December 3, 2014
First Posted (Estimate)
December 5, 2014
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-5570
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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