Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.

Key facts

Study ID

NCT04849780

Run by

Johnson & Johnson Vision Care, Inc.

People needed

95

Starts

2021-04-17

Expected to finish

2021-08-12

Last updated by the study team

2022-10-10

Who can join

Age: 18 and older, up to 59. 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 59 (inclusive) years of age at the time of screening.
• Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report.
• Have a CLDEQ-8 score of 15 or greater with the habitual lens.
• Subjects must possess a pair of spectacles for distance correction.
• Subject's habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision® MyDay®, or Johnson \& Johnson 1-Day ACUVUE® Moist.
• The subject's vertex corrected spherical distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
• The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye.
• Have spherical best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if…

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Subject's habitual lens is ACUVUE OASYS®1-Day.
• Currently pregnant or lactating, by self-report.
• Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
• Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
• Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
• Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal.
• . Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
• Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
• Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (Rx or over the counter (OTC)) that may interfere with contact lens wear (at the discretion of the investigator).
• 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 Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.

Where it is running

• Vue Optical Boutique — Jacksonville, Florida, United States
• Sabal Eye Care — Longwood, Florida, United States
• Maitland Vision Center — Maitland, Florida, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Sacco Eye Group — Vestal, New York, United States
• Procare Vision Centers — Granville, Ohio, United States
• Dr. David Ferris & Associates — Warwick, Rhode Island, United States
• Optometry Group Pllc — Memphis, Tennessee, United States
• Tyler Eye Associates — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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