Visual Acuity
Conditions
Brief summary
Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate that the investigational contact lens meets the design requirements related to corneal staining, lens fit, visual acuity and rotational performance as well as subjective comfort and handling. Subjects will wear the contact lenses for a total of 28-36 days.
Interventions
Senofilcon C Toric
DEVICEMarketed Contact Lens
Air Optix for Astigmatism
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\) Healthy adult males or females age ≥18-40 years of age with signed informed consent. 2\) The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3\) Subject must be a habitual soft toric contact lens wearer. Habitual wearer is defined as someone who wears contact lenses for at least 6 hours a day, 5 days a week for the past 30 days. 4\) Subject's vertex corrected spherical component of their distance refraction must be between -1.00 to -4.75 Diopter (D) (inclusive) in each eye. 5\) Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 DC (inclusive) in each eye. 6\) Subject's refractive cylinder axis must be 180±25 and 90±15 in each eye. 7) The subject must have visual acuity best correctable to 20/25 or better for each eye 8) The subject must read and sign the Informed Consent form.
Exclusion criteria
* 1\) Women who are pregnant or breastfeeding, 2) Any ocular or systemic allergies or diseases that may contraindicate contact lens wear. 3\) Any ocular medications use within the last one month. 4) Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 5\) Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report. 6\) Habitual wearer of extended wear contact lenses. 7) Known sensitivity to Revitalens OcuTec® 8) Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 9\) A clinical finding or history of entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report. 10\) History of binocular vision abnormality or strabismus, by self-report. 11) Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 12\) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician). 13\) Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 14\) Clinically significant (grade 3 or higher) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities which would contraindicate contact lens wear. 15\) Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear. 16\) Any active ocular infection. 17) Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 18\) Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | Up to 4-Week Follow-up | Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type. |
| Lens Fit Acceptance | 15 Minutes Post Lens Fitting | Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens. |
| Lens Stability With Blink | 15 Minutes Post Lens Fitting | Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens. |
| Absolute Lens Rotation | 15-minutes Post Lens Insertion | Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported. |
| Monocular Distance Visual Acuity (VA) | Up to 4-Week Follow-up | Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was 20/40 or better (acceptable VA) or worse than 20/40 (unacceptable VA). VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Handling | Up to 4- 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 Distance Visual Acuity (VA) | 15 Minutes Post Lens Fitting | Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet. Observed VA data collected at fitting were dichotomized whether VA was 20/20 or better (optimal VA) or worse than 20/20. VA of 20/20 with a negative modifier was considered worse than 20/20. The number of eyes with 20/20 vision was reported for each study lens. |
| Overall Comfort | Up to 4- 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. |
Countries
United States
Participant flow
Recruitment details
A total of 267 subjects were enrolled into this study. Of the enrolled 262 were randomized to receive a study lens, while 5 subjects failed to meet the eligibility criteria. Of the 262 randomized subjects, 231 completed the study and 31 subjects were discontinued.
Pre-assignment details
One subject was randomized to the Test lens but in actuality was dispensed the control lens, therefore his/her data was summarized with the control data, while this/her demographic information is apart of the Test summary.
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon B (Control) Subjects that wore the lotrafilcon B lens throughout the entire duration of the study. | 132 |
| Senofilcon C Toric (Test) Subjects that wore the senofilcon C toric lens throughout the entire duration of the study. | 130 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lens Damage | 1 | 6 |
| Overall Study | Lens Discomfort | 2 | 1 |
| Overall Study | Lost Lens | 2 | 5 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | No Longer Meets Eligibility Criteria | 0 | 1 |
| Overall Study | Product quality complaint | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 4 |
| Overall Study | Test Article No Longer Available | 1 | 0 |
| Overall Study | Unsatisfactory Lens Fitting | 0 | 1 |
Baseline characteristics
| Characteristic | Lotrafilcon B (Control) | Senofilcon C Toric (Test) | Total |
|---|---|---|---|
| Age, Continuous | 29.3 Years STANDARD_DEVIATION 6.5 | 29.4 Years STANDARD_DEVIATION 5.81 | 29.4 Years STANDARD_DEVIATION 6.16 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants | 12 Participants | 25 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 110 Participants | 111 Participants | 221 Participants |
| Region of Enrollment United States | 132 Participants | 130 Participants | 262 Participants |
| Sex: Female, Male Female | 95 Participants | 74 Participants | 169 Participants |
| Sex: Female, Male Male | 37 Participants | 56 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 130 |
| other Total, other adverse events | 0 / 132 | 0 / 130 |
| serious Total, serious adverse events | 0 / 132 | 0 / 130 |
Outcome results
Primary
Absolute Lens Rotation
Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported.
Time frame: 15-minutes Post Lens Insertion
Population: All subjects who administered the test article and have at least one observation after lens insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C Toric (Test) | Absolute Lens Rotation | 255 Eyes |
| Lotrafilcon B (Control) | Absolute Lens Rotation | 261 Eyes |
Comparison: Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.95% CI: [97.5, 99.9]Linear mixed model with binomial dist.
Primary
Corneal Staining
Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type.
Time frame: Up to 4-Week Follow-up
Population: All subjects who administered the test article and have at least one observation after lens insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C Toric (Test) | Corneal Staining | 0 Eyes |
| Lotrafilcon B (Control) | Corneal Staining | 3 Eyes |
Comparison: Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.95% CI: [0.004, 1.437]Bayesian beta-binomial model
Primary
Lens Fit Acceptance
Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects who administered the test article and have at least one observation after lens insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C Toric (Test) | Lens Fit Acceptance | 258 Eyes |
| Lotrafilcon B (Control) | Lens Fit Acceptance | 264 Eyes |
Comparison: Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.95% CI: [96.5, 100]Binomial proportion with Agrestic-Coull
Primary
Lens Stability With Blink
Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects who administered the test article and have at least one observation after lens insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C Toric (Test) | Lens Stability With Blink | 258 Eyes |
| Lotrafilcon B (Control) | Lens Stability With Blink | 264 Eyes |
Comparison: Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.95% CI: [96.5, 100]Binomial proportion with Agrestic-Coull
Primary
Monocular Distance Visual Acuity (VA)
Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was 20/40 or better (acceptable VA) or worse than 20/40 (unacceptable VA). VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens.
Time frame: Up to 4-Week Follow-up
Population: All subjects who administered the test article and have at least one observation after lens insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C Toric (Test) | Monocular Distance Visual Acuity (VA) | 258 Eyes |
| Lotrafilcon B (Control) | Monocular Distance Visual Acuity (VA) | 263 Eyes |
Comparison: Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.95% CI: [96.5, 100]Binomial proportion with Agresti-Coull
Secondary
Monocular Distance Visual Acuity (VA)
Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet. Observed VA data collected at fitting were dichotomized whether VA was 20/20 or better (optimal VA) or worse than 20/20. VA of 20/20 with a negative modifier was considered worse than 20/20. The number of eyes with 20/20 vision was reported for each study lens.
Time frame: 15 Minutes Post Lens Fitting
Population: All subjects who have successfully completed all required visits without any major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C Toric (Test) | Monocular Distance Visual Acuity (VA) | 177 Eyes |
| Lotrafilcon B (Control) | Monocular Distance Visual Acuity (VA) | 184 Eyes |
Comparison: Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.95% CI: [0.98, 3.22]Generalized LMM w/ binomial dist.
Secondary
Overall Comfort
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: Up to 4- Week Follow-up
Population: All subjects who have successfully completed all required visits without any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon C Toric (Test) | Overall Comfort | 61.4 Units on a Scale | Standard Deviation 23.45 |
| Lotrafilcon B (Control) | Overall Comfort | 52.0 Units on a Scale | Standard Deviation 24.45 |
Comparison: Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.95% CI: [2.1, 11.5]Linear mixed model
Secondary
Overall Handling
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: Up to 4- Week Follow-up
Population: All subjects who have successfully completed all required visits without any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon C Toric (Test) | Overall Handling | 63.5 Units on a Scale | Standard Deviation 20.9 |
| Lotrafilcon B (Control) | Overall Handling | 65.7 Units on a Scale | Standard Deviation 19.77 |
Comparison: Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.95% CI: [-7.2, 0.9]Linear mixed model