Ocular Characteristics in Contact Lens and Spectacle Wear

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.

Key facts

Study ID

NCT03913377

Run by

Johnson & Johnson Vision Care, Inc.

People needed

78

Starts

2019-04-09

Expected to finish

2019-06-14

Last updated by the study team

2021-02-04

Who can join

Age: 18 and older, up to 42. 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 will have completed the pre-screening Classification questionnaire.
• Subject must have a working cell phone capable of sending and receiving text messages.
• 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 42 (inclusive) years of age at the time of screening
• Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
• Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
• Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
• The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
• The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
• Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
• Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD \& OS.

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, by self-report
• Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
• Any active ocular abnormalities/conditions that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
• 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
• Habitual spectacle contains an add power, photochromic or tint.
• 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 OTC) that may interfere with contact lens wear and/or participation in the study (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 (CTP-2018).
• Accommodative/binocular dysfunction, determined by study procedures.

Where it is running

• VRC-East — Jacksonville, Florida, United States
• Sabal Eye Care — Longwood, Florida, United States
• Manhattan Vision Associates — New York, New York, United States

Full record on ClinicalTrials.gov

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