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Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05554640
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
2.9
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.

Condition or Disease Intervention/Treatment Phase
  • Device: Acuvue® Oasys MAX 1-Day
  • Device: Dailies Total 1
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses
Anticipated Study Start Date :
Oct 3, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test/Control

Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.

Device: Acuvue® Oasys MAX 1-Day
TEST Lens

Device: Dailies Total 1
CONTROL Lens
Experimental: Control/Test

Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.

Device: Acuvue® Oasys MAX 1-Day
TEST Lens

Device: Dailies Total 1
CONTROL Lens

Outcome Measures

Primary Outcome Measures

  1. Lens Fit Acceptance [At 2-week follow-up]

    Lens fit acceptance will be assessed at dispensing and follow-up visits for each subject eye. Acceptable fit is a binary response where Y=1 if lens fit is deemed acceptable by the investigator and Y=0 otherwise.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

  3. Between 18 and 40 (inclusive) years of age at the time of screening.

  4. They agree not to participate in other clinical research while enrolled on this study.

  5. They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.

  6. They own a wearable pair of spectacles if needed for distance vision correction (by self-report).

  7. They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.

  8. They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).

  9. They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).

Exclusion Criteria:
  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating.

  2. 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 or may pose a risk to study personnel.

  3. They have an ocular disorder which would normally contraindicate contact lens wear.

  4. They have had cataract surgery.

  5. They have had corneal refractive surgery.

  6. They are using any topical medications such as eye drops or ointments.

  7. Any known hypersensitivity or allergic reaction to sodium fluorescein.

  8. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.

  9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.

  10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

  11. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

  12. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 13. They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Manchester Manchester United Kingdom M13 9PL

Sponsors and Collaborators

  • Johnson & Johnson Vision Care, Inc.

Investigators

  • Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT05554640
Other Study ID Numbers:
  • CR-6495
First Posted:
Sep 26, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Oct 4, 2022