Clinical Evaluation of Etafilcon A With Ketotifen

Completed · Phase 2 · Has a placebo group

Conditions studied: Visual Acuity

In brief

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.

Key facts

Study ID

NCT03388138

Run by

Johnson & Johnson Vision Care, Inc.

People needed

143

Starts

2017-12-06

Expected to finish

2018-02-09

Last updated by the study team

2022-03-17

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Vue Optical Boutique — Jacksonville, Florida, United States
• Maitland Vision Center — Maitland, Florida, United States
• St. Lucy's Vision Center — Tampa, Florida, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Sacco Eye Group — Vestal, New York, United States
• Botetourt Eyecare, LLC — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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