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This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL | Experimental | For Phase 2, eligible subjects that are enrolled will be randomized to the Test/Control contralateral sequence. |
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| CONTROL/TEST | Experimental | For Phase 2, eligible subjects that are enrolled will be randomized to the Control/Test contralateral sequence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRP-200 | Device | JJVC Investigational Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photopic Contrast Sensitivity at 6 Cpd | Photopic (~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2. | Post screening up to 1 hour during Phase 1 |
| Mesopic Contrast Sensitivity at 6 Cpd | Mesopic (~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2. | Post screening up to 1 hour during Phase 1 |
| Photopic Resolution Acuity Using Landolt C's With a Glare Source | Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity. | At least 5 minutes post lens fitting up to 2 hours during Phase 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Photopic Contrast Sensitivity With a Glare Source | Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (~120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
For Phase I be between 18-39 (inclusive) years of age at the time of screening.
For Phase II be between 18 and 70 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical silicone hydrogel 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 5 days per week during the past 30 days.
Possess a wearable pair of spectacles that provide correction for distance vision.
Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye.
For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS.
For Phase II, the spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
For Phase II, the magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.
For Phase II, the best corrected, monocular, distance visual acuity must be 20/25 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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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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In Phase I, 20 subjects were enrolled and completed this Phase. In Phase 2, 62 subjects were enrolled. Of those enrolled in Phase 2, all 62 were dispensed at least 1 study lens. Of those dispensed, 60 subjects completed Phase 2 while 2 subjects were discontinued from Phase 2.
Phase I and Phase II are mutually exclusive. Data collected from Phase I was used to validate the glare light source for evaluating the primary and secondary endpoints in Phase II.
| ID | Title | Description |
|---|---|---|
| FG000 | OD: Test (Senofilcon A C3) /OS: Control (Senofilcon A C3) (Phase 2) | Subjects randomized to this sequence received the Test lens on the right eye and received the Control lens on the left eye |
| FG001 | OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3) (Phase 2) | Subjects randomized to this sequence received the Control lens on the right eye and received the Test lens on the left eye |
| FG002 | Subjects' Own Contact Lens (Phase 1) | Subjects enrolled into this phase used the following marketed contact lenses: senofilcon A (1-Day), senofilcon A (2-week reusable), senofilcon A C3, lotrafilcon B, comifilcon A, somofilcon A, delefilcon A, and stenfilcon A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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All subjects enrolled and completed in Phase 1. All subjects dispensed in Phase 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 | Phase 1 was a non-randomized design where subjects wore their own contact lenses |
| BG001 | Phase 2 | Phase 2 was a randomized design with two test articles |
| 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 | Photopic Contrast Sensitivity at 6 Cpd | Photopic (~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2. | All subjects that completed Phase 1 without a major protocol deviation excluding subjects recording an increase in photopic contrast sensitivity with the glare source. | Posted | Mean | Standard Deviation | Log Unit | Post screening up to 1 hour during Phase 1 | Eyes | Eyes |
|
Throughout the duration of the study; Phase 1 was approximately 1 hour per subject. Phase 2 was approximately 3 hours 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 | Phase 1 - Senofilcon A (1-Day) | Subjects enrolled into Phase I of the study with senofilcon A (1-Day) as their own contact lens. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch, O.D., M.S., F.A.A.O. | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | jbuch@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 | Aug 30, 2021 | Oct 13, 2022 | Prot_SAP_000.pdf |
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In Phase 2, subjects will be randomized to a contralateral sequence where the study lenses will be worn throughout the duration of the study.
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| ACUVUE Oasys 1-Day | Device | JJVC Marketed Contact Lens |
|
|
| At least 5 minutes post lens fitting up to 2 hours during Phase 2 |
| Mesopic Contrast Sensitivity With a Glare Source | Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity. | At least 5 minutes post lens fitting up to 2 hours during Phase 2 |
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| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
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| OG001 | Without Glare | Subject with photopic contrast sensitivity measured without a broadband glare source during Phase 1. |
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| Primary | Mesopic Contrast Sensitivity at 6 Cpd | Mesopic (~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2. | All subjects completed Phase 1 without a major protocol deviation excluding subjects recording an increase in mesopic contrast sensitivity with the glare source. | Posted | Mean | Standard Deviation | Log Unit | Post screening up to 1 hour during Phase 1 | Eyes | Eyes |
|
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| Primary | Photopic Resolution Acuity Using Landolt C's With a Glare Source | Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Mean | Standard Deviation | logMAR | At least 5 minutes post lens fitting up to 2 hours during Phase 2 | Eyes | Eyes |
|
|
|
|
| Secondary | Photopic Contrast Sensitivity With a Glare Source | Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (~120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Mean | Standard Deviation | Units on a scale | At least 5 minutes post lens fitting up to 2 hours during Phase 2 | Eyes | Eyes |
|
|
|
| Secondary | Mesopic Contrast Sensitivity With a Glare Source | Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Mean | Standard Deviation | Units on a scale | At least 5 minutes post lens fitting up to 2 hours during Phase 2 | Eyes | Eyes |
|
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|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Phase 1 - Senofilcon A (2-week Reusable) | Subjects enrolled into Phase I of the study with senofilcon A (2-week reusable) as their own contact lens. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Phase 1 - Senofilcon A C3 | Subjects enrolled into Phase I of the study with senofilcon A C3 as their own contact lens. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Phase 1 - Lotrafilcon B | Subjects enrolled into Phase I of the study with lotrafilcon B as their own contact lens. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG004 | Phase 1 - Comifilcon A | Subjects enrolled into Phase I of the study with comifilcon A as their own contact lens. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | Phase 1 - Somofilcon A | Subjects enrolled into Phase I of the study with somofilcon A as their own contact lens. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG006 | Phase 1 -Delefilcon A | Subjects enrolled into Phase I of the study with delefilcon A as their own contact lens. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG007 | Phase 1 -Stenfilcon A | Subjects enrolled into Phase I of the study with stenfilcon A as their own contact lens. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG008 | Phase 2 - Control (Senofilcon A C3) | Subjects that wore the Control lens in either eye during Phase 2 of the study. | 0 | 62 | 0 | 62 | 0 | 62 |
| EG009 | Phase 2 - Test (Senofilcon A C3) | Subjects that wore the Test lens in either eye during Phase 2 of the study. | 0 | 62 | 0 | 62 | 0 | 62 |
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| Other |
The least-square means (i.e., adjusted means) of mesopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made. |
| Superiority |
Superiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0. |