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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Participating Subjects | Experimental | Subjects who are habitual soft toric contact lens wearers, aged 18 to 40 years of age, will be dispensed the investigational contact lens to be worn from 28-36 days, to include a total of 5 visits. |
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| Control: Participating Subjects | Active Comparator | Subjects who are habitual soft toric contact lens wearers, aged 18 to 40 years of age, will be dispensed marketed contact lens to be worn from 28-36 days, to include a total of 5 visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Contact Lens | Device | Senofilcon C Toric |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4-Week Follow-up |
| 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. | 15 Minutes Post Lens Fitting |
| 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. | 15 Minutes Post Lens Fitting |
| 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. | 15-minutes Post Lens Insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Dr. James Weber & Associates, PA |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B (Control) | Subjects that wore the lotrafilcon B lens throughout the entire duration of the study. |
| FG001 | Senofilcon C Toric (Test) | Subjects that wore the senofilcon C toric lens throughout the entire duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2017 | Apr 30, 2018 |
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| Marketed Contact Lens |
| Device |
Air Optix for Astigmatism |
|
| 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. |
| Up to 4-Week Follow-up |
| Up to 4- Week Follow-up |
| 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. | Up to 4- Week Follow-up |
| 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. | 15 Minutes Post Lens Fitting |
| Jacksonville |
| Florida |
| 32205 |
| United States |
| Edward S. Wygonik, OD | Jacksonville Beach | Florida | 32250 | United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Indiana University School of Optometry | Bloomington | Indiana | 47405 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| ABQ Eye Care | Albuquerque | New Mexico | 87109 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| EyeCare Professionals of Powell | Powell | Ohio | 43065 | United States |
| Professional Vision Care, Inc | Westerville | Ohio | 43081 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Premier Vision | Amarillo | Texas | 79119 | United States |
| William J Bogus, OD, FAAO | Salt Lake City | Utah | 84106 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects that were randomized to a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lotrafilcon B (Control) | Subjects that wore the lotrafilcon B lens throughout the entire duration of the study. |
| BG001 | Senofilcon C Toric (Test) | Subjects that wore the senofilcon C toric lens throughout the entire duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects who administered the test article and have at least one observation after lens insertion. | Posted | Number | Eyes | Up to 4-Week Follow-up | Number of Eyes | Number of Eyes |
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| 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. | All subjects who administered the test article and have at least one observation after lens insertion. | Posted | Number | Eyes | 15 Minutes Post Lens Fitting | Number of Eyes | Number of Eyes |
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| 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. | All subjects who administered the test article and have at least one observation after lens insertion. | Posted | Number | Eyes | 15 Minutes Post Lens Fitting | Number of Eyes | Number of Eyes |
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| 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. | All subjects who administered the test article and have at least one observation after lens insertion. | Posted | Number | Eyes | 15-minutes Post Lens Insertion | Number of Eyes | Number of Eyes |
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| 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. | All subjects who administered the test article and have at least one observation after lens insertion. | Posted | Number | Eyes | Up to 4-Week Follow-up | Number of Eyes | Number of Eyes |
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| 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. | All subjects who have successfully completed all required visits without any major protocol deviations. | Posted | Mean | Standard Deviation | Units on a Scale | Up to 4- Week Follow-up |
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| 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. | All subjects who have successfully completed all required visits without any major protocol deviations. | Posted | Mean | Standard Deviation | Units on a Scale | Up to 4- Week Follow-up |
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| 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. | All subjects who have successfully completed all required visits without any major protocol deviations. | Posted | Number | Eyes | 15 Minutes Post Lens Fitting | Number of Eyes | Number of Eyes |
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Throughout the duration of the study. Approximately 1 month per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lotrafilcon B (Control) | Subjects that wore the lotrafilcon B lens throughout the entire duration of the study. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG001 | Senofilcon C Toric (Test) | Subjects that wore the senofilcon C toric lens throughout the entire duration of the study. | 0 | 130 | 0 | 130 | 0 | 130 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristy Canavan- SENIOR PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision | 904 443-1474 | KCANAVA2@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2017 | Apr 30, 2018 | SAP_001.pdf |
| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific |
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| White |
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| Other |
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It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes. |
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