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This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test1/Test2/Control/Test3 | Experimental | Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. |
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| Test2/Test3/Test1/Control | Experimental | Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. |
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| Test3/Control/Test2/Test1 | Experimental | Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. |
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| Control/Test1/Test3/Test2 | Experimental | Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon a Test 1 | Device | 1-DAY ACUVUE® MOIST |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microsphere Clearance Rate | The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance. | Post microsphere application over a 30 minute period |
| Microsphere Uptake Rate | The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake. | Post microsphere application over a 10 minute period |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Movement | Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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 between 18 and 40 (inclusive) years of age at the time of screening.
The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.
The subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report.
The subject must agree not to participate in other clinical research for the duration of this study.
The subject's refractive cylinder must be <-1.25DC in each eye.
The subject must have best corrected visual acuity of 0.20 logMAR or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | M13 9PL | United Kingdom |
Subjects were randomized to 1 of 4 unique lens sequences.
A total of 34 subjects were enrolled into the study. Of the enrolled 9 subjects did not meet the eligibility criteria. 22 subjects completed the study and 3 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 1\Control\Test 2\Test 3 | Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, and Test 3 in period 4. |
| FG001 | Test 2\Test 1\Test 3\Control | Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, and Control in period 4. |
| FG002 | Control\Test 3\Test 1\Test 2 | Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 3 in period 2, Test 1 in period 3, and Test 2 in period 4. |
| FG003 | Test 3\Test 2\Control\Test 1 | Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Control in period 3, and 1 Test 1 in period 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | All subjects dispensed a study lens. |
| 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 |
| 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 | Microsphere Clearance Rate | The rate of microsphere clearance from the post-lens tear film was assessed by the C30 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where lens wear was assigned, the microsphere suspension was dispensed onto the posterior concave contact lens surface immediately prior to lens application. A series of digital images were taken over a 30-minute period (every minute for the first 10 minutes and then every 5 minutes for the next 20 minutes). Data transformed from the images were calculated by the C30 image analysis metric. Higher numbers represented greater clearance. The right eye was used to evaluate microsphere clearance. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol | Posted | Mean | Standard Deviation | percent clearance | Post microsphere application over a 30 minute period | eyes | eyes |
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Throughout the duration of the study. Approximately 13 weeks.
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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 | Test 1 | Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unconfirmed Corneal Endothelium Keratic Precipitate | Eye disorders | Systematic Assessment | Unconfirmed Corneal Endothelium Keratic Precipitate was reported in the right eye. The adverse event was deemed unrelated to the study by the investigator and the subject was discontinued. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. | 904 443-3402 | 2126 | TKarkkai@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2018 | Mar 24, 2020 | Prot_SAP_000.pdf |
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|
| etafilcon A Test 2 | Device | 1-DAY ACUVUE® MOIST for ASTIGMATISM |
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| etafilcon A Test 3 | Device | 1-DAY ACUVUE® MOIST MULTIFOCAL |
|
| Control | Other | Bare Eye |
|
| Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS) |
| Corneal Curvature | Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal. | Baseline |
| Corneal Curvature | Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured. | Baseline |
| Blink Rate | Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported. | Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | Participants |
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Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study |
| OG001 | Test 2 | Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study |
| OG002 | Test 3 | Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study |
| OG003 | Control (Bare Eye) | Subjects were under the bare eye condition in either the first, second, third, or fourth period of the study. |
|
|
|
| Primary | Microsphere Uptake Rate | The rate of microsphere uptake into the post-lens tear film was assessed by the U5 image analysis metric. Where bare eye was assigned, a droplet of microsphere suspension was applied directly onto the superior temporal conjunctiva. Where a lens was assigned the lens was applied and after a 10-minute settling period, a droplet of microsphere suspension was applied directly to the superior temporal conjunctiva. A series of digital images were taken over a 10-minute period (every minute for 10 minutes). Data transformed from the images were calculated by the U5 image analysis metric. Higher numbers represented greater uptake rate. The left eye was used to evaluate microsphere uptake. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol | Posted | Mean | Standard Deviation | percent uptake | Post microsphere application over a 10 minute period | eyes | eyes |
|
|
|
|
| Secondary | Lens Movement | Lens movement was assessed for primary gaze, up-gaze, and push up by clinical grading. Primary gaze movement was evaluated by observing the vertical movement of the contact lens that occurs with a full blink without manipulating the subject's lids. Up-gaze movement was assessed by estimating the vertical lens movement observed when the subject looks up and blinks fully without manipulating the subject's lids. The push-up test consists of a gentle digital push of the lens upwards using the lower lid. The resistance of the lens to of the lens to upward movement is judged. Lens movement was graded according to the following scale: Excessive (+2), Moderate movement (+1), Optimal (0), Minimal (-1), and Insufficient (-2). All available data for lens movement in the safety population were reported. | All subjects dispensed a study lens. | Posted | Count of Units | eyes | Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS) | eyes | eyes |
|
|
|
| Secondary | Corneal Curvature | Corneal curvature was assessed by Visante™ OCT. The following were measured: Sclera Angle-Temporal and Sclera Angle-Nasal. | All subjects dispensed a study lens. | Posted | Mean | Standard Deviation | Degree | Baseline | eyes | eyes |
|
|
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| Secondary | Corneal Curvature | Corneal curvature was assessed by Visante™ OCT. Sagital Height was measured. | All subjects dispensed a study lens. | Posted | Mean | Standard Deviation | Millimeter | Baseline | eyes | eyes |
|
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| Secondary | Blink Rate | Blinking characteristics were captured using an infra-red camera (FLIR Grasshopper 3 camera) and infra-red LED illumination (Thorlabs LIU780A). During video capture the subject was directed to view a wildlife video on an Ipad at a working distance of approximately 1 meter. The infrared video was captured for 3 minutes at 500 frames per second. Subsequent video analysis recorded the blink rate (blinks per minute) over the 3-minute period. Baseline values were reported across all subjects who were dispensed a study lens. Blink rate post microsphere application was reported by treatment. All available data for blink rate in the safety population were reported. | All subjects dispensed a study lens. | Posted | Mean | Standard Deviation | blinks per minute | Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye. | eyes | eyes |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Test 2 | Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study | 0 | 25 | 1 | 25 | 0 | 25 |
| EG002 | Test 3 | Subjects that wore the Test 1 lens in either the first, second, third, or fourth period of the study | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Control (Bare Eye) | Subjects were under bare eye condition in either the first, second, third, or fourth period of the study. | 0 | 25 | 0 | 25 | 0 | 25 |
|
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| eyes |
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| Testing equivalence with respect to microsphere uptake rate. | Mixed Models Analysis | Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach. | Mean Difference (Final Values) | 6.6 | Standard Error of the Mean | 4.95 | 2-Sided | 99.1 | -7.8 | 20.9 | Test 2 - Control | Equivalence | Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%. |
| Testing equivalence with respect to microsphere uptake rate. | Mixed Models Analysis | Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach. | Mean Difference (Final Values) | 2.9 | Standard Error of the Mean | 6.22 | 2-Sided | 99.1 | -15.1 | 20.9 | Test 3 - Control | Equivalence | Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%. |
| Testing equivalence with respect to microsphere uptake rate. | Mixed Models Analysis | Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach. | Mean Difference (Final Values) | -5.5 | Standard Error of the Mean | 5.13 | 2-Sided | 99.1 | -20.4 | 9.4 | Test 3 - Test 1 | Equivalence | Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%. |
| Testing equivalence with respect to microsphere uptake rate. | Mixed Models Analysis | Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach. | Mean Difference (Final Values) | -3.7 | Standard Error of the Mean | 3.10 | 2-Sided | 99.1 | -12.6 | 5.3 | Test 3 - Test 2 | Equivalence | Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%. |
| Testing equivalence with respect to microsphere uptake rate. | Mixed Models Analysis | Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach. | Mean Difference (Final Values) | -1.8 | Standard Error of the Mean | 4.18 | 2-Sided | 99.1 | -13.9 | 10.3 | Test 2 - Test 1 | Equivalence | Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%. |
| Optimal(0) |
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| Moderate(+1) |
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| Excessive(+2) |
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| Push Up |
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| Up-gaze |
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| eyes |
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| Post Lens Insertion |
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