Ocular Characteristics in Contact Lens and Spectacle Wear

NCT03913377 | Completed Results FDA Device

• 1 other identifier: CR-6332
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT)

  NIBUT/NIKBUT was measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. NIBUT is measured by a topographer (e.g. Medmont) via observation by the investigator and a stopwatch. NIKBUTis measured by the Oculus Keratograph and reported by the instrument. Different instrumentation was used depending on site availability. Combined measurements of pre-lens data collected for the interventional arm are reported. Only the interventional arm was reported since the primary analysis was conducted among habitual contact lens users. The average NIKBUT was reported for each treatment. Higher values indicate better performance

  1-Week Follow-up

Secondary Outcomes (4)

• Total Scores of Meibomian Gland Expressibility (MGE)

  1-Week Follow-up

• Conjunctival Staining

  1-Week Follow-up

• Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy

  1-Week Follow-up

• Meibomian Gland Expressibility (MGE) Grades

  1-Week Follow-up

Study Arms (2)

Observational

EXPERIMENTAL

Eligible subjects that are habitual spectacle wearers will use their habitual optical correction and undergo ocular evaluations and questionnaires at the baseline and 1-week visit.

Device: Spectacles

Interventional

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers who own spectacles will be randomized into 1 of 2 sequences (Spectacle/ACUVUE OASYS 1-Day or ACUVUE OASYS 1-Day/Spectacle)

Device: Spectacles; Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology

Interventions

Spectacles DEVICE

Subjects' own habitual spectacles

Interventional; Observational

ACUVUE OASYS®1-Day with HydraLuxe™ Technology DEVICE

Test 1

Interventional

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (3)

VRC-East

Jacksonville, Florida, 32256, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Manhattan Vision Associates

New York, New York, 10022, United States

Location

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Limitations and Caveats

No study limitations were reported for this study.

Results Point of Contact

• Title: Elizabeth Dow, PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care

edow1@its.jnj.com

+1800-843-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: April 9, 2019
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: February 4, 2021
• Results First Posted: August 6, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)