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Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

Primary Purpose

Ocular Physiology

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock
Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Physiology

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: 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. Be between 18 and 39 years of age (inclusive) at the time of screening. Habitually wear soft contact lenses (either sphere or toric) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks. Possess a wearable pair of spectacles that provide correction for distance vision. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -9.00 DS (inclusive) in both eyes. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 3.00 DC (inclusive) in both eyes. Have best corrected monocular distance VA of 20/30 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: Be currently pregnant or lactating. Be diabetic. Be currently using any ocular medications or have an ocular infection of any type. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. Be currently wearing monovision or multifocal contact lenses or be currently wearing lenses in an extended wear modality. Have a history of strabismus or amblyopia. Be an employee (e.g., Investigator, Coordinator, Technician) or family member of an employee of investigational clinic. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

Sites / Locations

  • VRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Test/Control

Control/Test

Arm Description

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.

Outcomes

Primary Outcome Measures

Percentage of eyes with 'moderate' or 'severe' subject-reported ocular symptoms
Frequency and severity by eye of subject-reported ocular symptoms and problems with the study lens following lens settling and again following at least 1 hour of bilateral study lens wear. Severity of the symptoms can be: 0 = Not Applicable or Not Recorded; = Mild and results in little or no interference with lens wear; = Moderate AND/OR occasionally interferes with lens wear; = Severe AND/OR frequently interferes with lens wear.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
February 21, 2023
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05713552
Brief Title
Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock
Official Title
Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

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

5. Study Description

Brief Summary
This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Physiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test/Control
Arm Type
Experimental
Arm Description
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.
Arm Title
Control/Test
Arm Type
Experimental
Arm Description
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.
Intervention Type
Device
Intervention Name(s)
Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock
Intervention Description
CONTROL
Intervention Type
Device
Intervention Name(s)
Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock
Intervention Description
TEST
Primary Outcome Measure Information:
Title
Percentage of eyes with 'moderate' or 'severe' subject-reported ocular symptoms
Description
Frequency and severity by eye of subject-reported ocular symptoms and problems with the study lens following lens settling and again following at least 1 hour of bilateral study lens wear. Severity of the symptoms can be: 0 = Not Applicable or Not Recorded; = Mild and results in little or no interference with lens wear; = Moderate AND/OR occasionally interferes with lens wear; = Severe AND/OR frequently interferes with lens wear.
Time Frame
Up to 1 hour of lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: 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. Be between 18 and 39 years of age (inclusive) at the time of screening. Habitually wear soft contact lenses (either sphere or toric) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks. Possess a wearable pair of spectacles that provide correction for distance vision. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -9.00 DS (inclusive) in both eyes. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 3.00 DC (inclusive) in both eyes. Have best corrected monocular distance VA of 20/30 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: Be currently pregnant or lactating. Be diabetic. Be currently using any ocular medications or have an ocular infection of any type. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. Be currently wearing monovision or multifocal contact lenses or be currently wearing lenses in an extended wear modality. Have a history of strabismus or amblyopia. Be an employee (e.g., Investigator, Coordinator, Technician) or family member of an employee of investigational clinic. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Vision Care, Inc. Clinical Trial
Organizational Affiliation
Johnson & Johnson Vision Care, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
VRC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

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