Status:
COMPLETED
Clinical Evaluation of Etafilcon A With Ketotifen
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2018
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03388138
Start Date
December 6 2017
End Date
February 9 2018
Last Update
March 17 2022
Active Locations (6)
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1
Vue Optical Boutique
Jacksonville, Florida, United States, 32205
2
Maitland Vision Center
Maitland, Florida, United States, 32751
3
St. Lucy's Vision Center
Tampa, Florida, United States, 33625
4
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762