Myopia; Astigmatism
Conditions
Brief summary
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
Interventions
DEVICEPrototype toric lens senofilcon A
Investigational prototype
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males or females that are ≥18 years of age and ≤39 years of age. * The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days. * Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye. * Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye. * Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye. * If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction. * Subject's best corrected distance acuity must be 20/25-2 or better in each eye.
Exclusion criteria
* Females who are currently pregnant or lactating. * Any ocular or systemic allergies or diseases that may contraindicate contact lens wear. * Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report. * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report. * Habitual wearer of extended wear contact lenses. * Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) * History of seizures. * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report. * History of binocular vision abnormality or strabismus, by self-report. * Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. * Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician). * Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. * Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale. * Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear. * Any active ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 | 7 day follow-up | Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported. |
| The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | 15 Minutes Post Insertion | Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported. |
| Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees | 15 Minutes Post Insertion | Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported. |
| Proportion of Subject Eyes With Acceptable Lens Fit | 15 Minute Post Insertion | Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported. |
Countries
United States
Participant flow
Pre-assignment details
A total of 177 subjects were enrolled into this study. Of the enrolled subjects, 7 did not meet the eligibility criteria and 170 subjects were dispensed a study lens. Of the dispensed subjects, 7 were discontinued and 163 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Prototype Toric Lens Senofilcon A All subjects in this study were dispensed the prototype toric lens senofilcon A in this study. | 170 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Study discontinued at site | 2 |
Baseline characteristics
| Characteristic | Prototype Toric Lens Senofilcon A |
|---|---|
| Age, Continuous | 28.8 Years STANDARD_DEVIATION 5.71 |
| Race/Ethnicity, Customized American Indian or Native Alaskian | 4 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Other | 7 Participants |
| Race/Ethnicity, Customized White | 131 Participants |
| Region of Enrollment United States | 170 participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 170 |
| serious Total, serious adverse events | 0 / 170 |
Outcome results
Primary
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
Time frame: 7 day follow-up
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prototype Toric Lens Senofilcon A | Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 | 1.0 proportion of Subject Eyes |
Primary
Proportion of Subject Eyes With Acceptable Lens Fit
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
Time frame: 15 Minute Post Insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prototype Toric Lens Senofilcon A | Proportion of Subject Eyes With Acceptable Lens Fit | 1.0 proportion of Subject Eyes |
Primary
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
Time frame: 15 Minutes Post Insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prototype Toric Lens Senofilcon A | Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees | 1.0 proportion of Subject Eyes |
Primary
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
Time frame: 15 Minutes Post Insertion
Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prototype Toric Lens Senofilcon A | The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | 0.993 proportion of Subject Eyes |