Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

NCT04849780 | Completed Results FDA Device

• 1 other identifier: CR-6388
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Comfort Score

  Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.

  Up to 2-Week Follow-up

Secondary Outcomes (3)

• Change From Baseline CLDEQ-8 Score

  Up to 2-Week Follow-up

• Comfort Score

  2-Week Follow-up

• CLDEQ-8 Score

  2-Week Follow-up

Study Arms (2)

ARM 1

EXPERIMENTAL

Eligible subjects will be randomized to the TEST lens to wear in both eyes for approximately 2 weeks.

Device: ACUVUE Oasys 1-Day

ARM 2

EXPERIMENTAL

Eligible subjects will be randomized to the CONTROL lens to wear in both eyes for approximately 2 weeks. Then the subject will receive the TEST lens to wear in both eyes for approximately 2 weeks.

Device: ACUVUE Oasys 1-Day; Device: Habitual Lens

Interventions

ACUVUE Oasys 1-Day DEVICE

TEST

ARM 1; ARM 2

Habitual Lens DEVICE

Subjects' own Habitual Lenses

Also known as: CONTROL

ARM 2

Eligibility Criteria

• Age: 18 Years - 59 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 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (9)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Sabal Eye Care

Longwood, Florida, 32792, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Procare Vision Centers

Granville, Ohio, 43023, United States

Location

Dr. David Ferris & Associates

Warwick, Rhode Island, 02888, United States

Location

Optometry Group Pllc

Memphis, Tennessee, 38111, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: John R. Buch, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care, Inc.

jbuch@its.jnj.com

1-800-846-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 19, 2021
• Study Start: April 17, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: October 10, 2022
• Results First Posted: October 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (9)