Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04794270
• Collaborator: (none)
• Enrollment: 72
• Locations: 5
• Arms: 2
• Actual Duration (Months): 1.4
• Patients Per Site: 14.4
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

This is a bilateral, dispensing, randomized, controlled, double-masked, 2×2 cross-over study to evaluate the clinical performance of ACUVUE OASYS® 1-Day for Astigmatism contact lenses produced on a recently qualified manufacturing line.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: ACUVUE OASYS® 1-Day for Astigmatism - TAM 24; Device: ACUVUE OASYS® 1-Day for Astigmatism	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line
• Actual Study Start Date: Mar 2, 2021
• Actual Primary Completion Date: Apr 13, 2021
• Actual Study Completion Date: Apr 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TEST/CONTROL Eligible subjects that are habitual contact lens wearers will be randomized into the (TEST/CONTROL) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period.	Device: ACUVUE OASYS® 1-Day for Astigmatism - TAM 24; TEST; Device: ACUVUE OASYS® 1-Day for Astigmatism; CONTROL
Experimental: CONTROL/TEST Eligible subjects that are habitual contact lens wearers will be randomized into the (CONTROL/TEST) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period.	Device: ACUVUE OASYS® 1-Day for Astigmatism - TAM 24; TEST; Device: ACUVUE OASYS® 1-Day for Astigmatism; CONTROL

Outcome Measures

Primary Outcome Measures

1. CLUE Comfort Score [Fitting, 1-Week Follow-up]

   Overall 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.

2. CLUE Vision Score [Fitting, 1-Week Follow-up]

   Overall vision 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.

3. CLUE Handling Score [Fitting, 1-Week Follow-up]

   Overall handling 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.

4. Monocular Visual Performance (LogMAR) [1-Week Follow-up]

   Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye. The average visual performance was reported for each lens type.

5. Lens Rotation [Post-Fitting at 1-minute, at 3-minute]

   Lens rotation was recorded from direction and magnitude in degrees to the nearest degree at one and three minutes following lens insertion during settling period. All lenses in this study have scribe marks at 6 o'clock and 12 o'clock positions and rotation measurements were made relative to a vertical reference line.

6. Settled Rotation [Fitting, 1-Week Follow-up]

   Mean settled rotation was calculated from all repeated measures of signed lens orientation upon settling for each subject/eye/lens.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 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:

The subject must:

1. 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. Be between 18 and 39 (inclusive) years of age at the time of screening.

4. By self-report, habitually wear soft contact lenses 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 of wear per day, for a minimum of 2 days per week during the past month.

5. Possess a wearable pair of spectacles that provide correction for distance vision.

6. Have the spherical component of their vertex-corrected distance refraction must be between -0.875 to -4.625 DS (inclusive) in each eye.

7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.625 DC and 1.625 DC in both eyes.

8. Have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive) in each eye.

9. Have best corrected monocular distance visual acuity 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:

1. Be currently pregnant or lactating.

2. Be diabetic.

3. Be currently using any ocular medications or have any ocular infection of any type.

4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures.

5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

6. Be currently wearing monovision or multifocal contact lenses.

7. Be currently wearing lenses in an extended wear modality.

8. Have a history of strabismus or amblyopia.

9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.

11. Have clinically significant (grade 3 or higher on the FDA grading 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 contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).

12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sabal Eye Care	Longwood	Florida	United States	32779
2	VisionPoint Eye Center	Bloomington	Illinois	United States	61704
3	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
4	Sacco Eye Group	Vestal	New York	United States	13850
5	Professional Vision Care, Inc.	Westerville	Ohio	United States	43081

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)

• Study Protocol and Statistical Analysis Plan - Nov 5, 2020

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04794270
• Other Study ID Numbers: CR-6420
• First Posted: Mar 12, 2021
• Last Update Posted: May 18, 2022
• Last Verified: Apr 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
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Recruitment Details	A total of 72 subjects were enrolled in this study. Of those enrolled, a total of 71 subjects were assigned to one of two wear sequences; while one subject was a screen failure and/or not assigned. Of the total assigned subjects, 68 subjects completed the study while, 3 subjects were discontinued from the study.

Arm/Group Title	Control/Test	Test/Control
Arm/Group Description	Subjects that wore the Control lens in a bilateral fashion during Period 1 and the Test lens during Period 2.	Subjects that wore the Test lens in a bilateral fashion during Period 1 and the Control lens during Period 2.
Period Title: Period 1
STARTED	35	36
COMPLETED	33	36
NOT COMPLETED	2	0
Period Title: Period 1
STARTED	33	36
COMPLETED	32	36
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Dispensed Subject
Arm/Group Description	All subjects dispensed a study article.
Overall Participants	71
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.5 (5.76)
Sex: Female, Male (Count of Participants)
Female	47 66.2%
Male	24 33.8%
Race/Ethnicity, Customized (participants) [Number]
Asian	1 1.4%
Black or African American	2 2.8%
White	67 94.4%
Other	1 1.4%
Region of Enrollment (participants) [Number]
United States	71 100%

Outcome Measures

1. Primary Outcome

Title	CLUE Comfort Score
Description	Overall 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.
Time Frame	Fitting, 1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.	All subjects that wore the Control lens during any of the 2 wear periods.
Measure Participants	58	58
Fitting	65.95 (18.645)	65.13 (18.849)
1-Week Follow-up	67.39 (20.024)	70.80 (22.742)

2. Primary Outcome

Title	CLUE Vision Score
Description	Overall vision 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.
Time Frame	Fitting, 1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.	All subjects that wore the Control lens during any of the 2 wear periods.
Measure Participants	58	58
Fitting	70.14 (15.979)	69.64 (15.767)
1-Week Follow-up	68.33 (18.349)	72.40 (19.381)

3. Primary Outcome

Title	CLUE Handling Score
Description	Overall handling 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.
Time Frame	Fitting, 1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.	All subjects that wore the Control lens during any of the 2 wear periods.
Measure Participants	58	58
Fitting	73.56 (19.057)	72.71 (20.760)
1--Week Follow-up	70.61 (21.048)	71.83 (19.740)

4. Primary Outcome

Title	Monocular Visual Performance (LogMAR)
Description	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye. The average visual performance was reported for each lens type.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.	All subjects that wore the Control lens during any of the 2 wear periods.
Measure Participants	58	58
Measure eye	116	116
Mean (Standard Deviation) [LogMAR]	-0.108 (0.0703)	-0.112 (0.0679)

5. Primary Outcome

Title	Lens Rotation
Description	Lens rotation was recorded from direction and magnitude in degrees to the nearest degree at one and three minutes following lens insertion during settling period. All lenses in this study have scribe marks at 6 o'clock and 12 o'clock positions and rotation measurements were made relative to a vertical reference line.
Time Frame	Post-Fitting at 1-minute, at 3-minute

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.	All subjects that wore the Control lens during any of the 2 wear periods.
Measure Participants	58	58
Measure eye	116	116
At 1-minute	-1.7 (14.65)	-2.0 (14.94)
At 3-minute	-1.1 (4.55)	-0.8 (4.88)

6. Primary Outcome

Title	Settled Rotation
Description	Mean settled rotation was calculated from all repeated measures of signed lens orientation upon settling for each subject/eye/lens.
Time Frame	Fitting, 1-Week Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.	All subjects that wore the Control lens during any of the 2 wear periods.
Measure Participants	58	58
Measure eye	116	116
Fitting	-0.9 (2.69)	-1.3 (2.80)
1-Week Follow-up	-1.8 (3.29)	-1.6 (3.26)

Adverse Events

Time Frame	Throughout the duration of the study; approximately 3 weeks per subject.
Arm/Group Title	Test		Control
Arm/Group Description	All subjects that wore the Test lens during any of the 2 wear periods.		All subjects that wore the Control lens during any of the 2 wear periods.
All Cause Mortality
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)
Serious Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.