- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388138
Clinical Evaluation of Etafilcon A With Ketotifen
March 8, 2022 updated by: Johnson & Johnson Vision Care, Inc.
This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study.
Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Phase 2
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
-
Maitland, Florida, United States, 32751
- Maitland Vision Center
-
Tampa, Florida, United States, 33625
- St. Lucy's Vision Center
-
-
Kansas
-
Pittsburg, Kansas, United States, 66762
- Kannarr Eye Care
-
-
New York
-
Vestal, New York, United States, 13850
- Sacco Eye Group
-
-
Virginia
-
Salem, Virginia, United States, 24153
- Botetourt Eyecare, LLC
-
-
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 40 years (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.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 18 and 39 (inclusive) years of age at the time of baseline visit.
- The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month.
- The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
- The subject's refractive cylinder must be 1.00 D or less in each eye.
Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating.
- Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear, history of strabismus, or current monovision, multi-focal, or toric contact lens correction.
- Any current use of rewetting drops or ocular medication.
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Biomicroscopy 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 would contraindicate contact lens wear.
- Any known hypersensitivity or allergic reaction to ketotifen.
- Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- Employee or immediate family member of an employee of clinical site (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 |
---|---|
Active Comparator: K-Lens
etafilcon A with ketotifen.
Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.
|
Etafilcon A with ketotifen
|
Placebo Comparator: Placebo Contact Lens
1-Day Acuvue.
Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.
|
1-Day ACUVUE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)
Time Frame: Baseline (Visit 1) and 1-week follow up (Visit 2)
|
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale.
This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts.
Distance visual acuity was reported by lens type and visit.
|
Baseline (Visit 1) and 1-week follow up (Visit 2)
|
Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population)
Time Frame: Baseline (Visit 1) and 1-week follow up (Visit 2)
|
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale.
This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts.
Distance visual acuity was reported by lens type and visit.
|
Baseline (Visit 1) and 1-week follow up (Visit 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Eyes With Clinically Significant Slit Lamp Findings
Time Frame: Up to 1-Week Follow-up
|
Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits.
Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe).
The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise.
The number of eyes with clinically significant slit lamp findings for each lens type was reported.
|
Up to 1-Week Follow-up
|
The Number of Eyes With Unacceptable Lens Fitting
Time Frame: Up to 1-Week Follow-up
|
Lens fit was assessed for each subject and eye using a biomicroscope.
Unacceptable lens fit was assessed at all scheduled and unscheduled visits.
A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test.
The number of eyes with unacceptable lens fitting was reported for each lens type.
|
Up to 1-Week 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)
December 6, 2017
Primary Completion (Actual)
February 9, 2018
Study Completion (Actual)
February 9, 2018
Study Registration Dates
First Submitted
December 22, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
January 2, 2018
Study Record Updates
Last Update Posted (Actual)
March 17, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-5930
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
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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