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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04794270

Enrollment

Registered

2021-03-12

Start date

2021-03-02

Completion date

2021-04-13

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

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.

Interventions

DEVICEACUVUE OASYS® 1-Day for Astigmatism - TAM 24

TEST

DEVICEACUVUE OASYS® 1-Day for Astigmatism

CONTROL

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

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.).

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.

Countries

United States

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.

Participants by arm

Arm	Count
Dispensed Subject All subjects dispensed a study article.	71
Total	71

Withdrawals & dropouts

Period	Reason	FG000
Period 1	Adverse Event	1
Period 1	Non Compliance	1
Period 2	Unsatisfactory Lens Fitting due to Test Article	1

Baseline characteristics

Characteristic	Dispensed Subject
Age, Continuous	29.5 years STANDARD_DEVIATION 5.76
Race/Ethnicity, Customized Asian	1 participants
Race/Ethnicity, Customized Black or African American	2 participants
Race/Ethnicity, Customized Other	1 participants
Race/Ethnicity, Customized White	67 participants
Region of Enrollment United States	71 participants
Sex: Female, Male Female	47 Participants
Sex: Female, Male Male	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 71	0 / 71
other Total, other adverse events	0 / 71	0 / 71
serious Total, serious adverse events	0 / 71	0 / 71

Outcome results

Primary

CLUE Comfort Score

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