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This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens/Control Lens | Experimental | Eligible subjects will be randomized into the Test Lens/Control Lens sequence, to wear the Test Lens followed by the Control Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods. |
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| Control Lens/Test Lens | Experimental | Eligible subjects will be randomized into the Control Lens/Test Lens sequence, to wear the Control Lens followed by the Test Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A with PVP with cosmetic pattern contact lens | Device | Test Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance Monocular logMAR Visual Acuity | Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | Fitting Evaluation |
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Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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 |
|---|---|---|---|---|---|---|
| Maitland Vision Center - North Orlando Ave | Maitland | Florida | 32751 | 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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A total of 53 subjects were enrolled in this study. All 53 enrolled subjects met all eligibility criteria and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (Etafilcon A)/Control (Etafilcon A) | Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period |
| FG001 | Control (Etafilcon A)/Test (Etafilcon A) | Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects dispensed at least one study contact lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Reporting Group | All subjects dispensed at least one study contact 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 | Distance Monocular logMAR Visual Acuity | Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | All subjects dispensed at least one study contact lens. All subjects who successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review prior to database lock. | Posted | Mean | Standard Deviation | logMAR | Fitting Evaluation | Eyes | Eyes |
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Throughout the duration of the study; approximately 1 day per subject.
All subjects dispensed at least one study lens.
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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 (Etafilcon A) | Subjects that wore the Test lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Contact - JJVC | Johnson & Johnson Vision Care | 1-800-843-2020 | jhunsade@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 | Feb 26, 2025 | May 4, 2026 | Prot_SAP_000.pdf |
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| 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey | Device | Control Lens |
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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 (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Control (Etafilcon A) | Subjects that wore the Control lens in either the first or second period of the study. |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control (Etafilcon A) | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 53 | 0 | 53 | 0 | 53 |
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