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To evaluate the clinical performance of daily disposable etafilcon A lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etafilcon A Control Lens | Active Comparator | etafilcon A |
|
| Etafilcon A Test Lens | Experimental | etafilcon A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device |
| ||
| etafilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120. | 1-week follow-up |
| Overall Vision | Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120. | 1- week Follow-up |
| Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim | LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision. | 1-week follow-up |
| Monocular logMar Visual Acuity - Standard Low Contrast Bright | LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | United States | ||||
128 of the 136 subjects were randomized. 8 subjects did not meet the eligibility criteria. 3 subjects were discontinued from the study. 12 subjects were excluded from analysis due to major protocol deviations. 113 subjects completed all study visits without a major protocol deviation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control/Test | Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A. |
| FG001 | Test/Control | Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
The analysis population consists of all randomized subjects. Randomized subjects are subjects that have signed informed consent and have been randomized to 1 of the 2 treatment arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control/Test | Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A. |
| BG001 | Test/Control |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Overall Comfort | Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120. | Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations. | Posted | Mean | Standard Deviation | units on a scale | 1-week follow-up |
|
One week for each intervention
Safety Population included all subjects who were administered at least 1 test article.
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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 | Control | Subjects who received control lens etafilcon A in either the first or the last week of the study . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, OD, MS, FAAO - Senior Principal Research Optometrist | Johnson & Johnson Vision Care, Inc | 904-443-3500 | 1290 | BPALL@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| 1- week Follow-up |
| Honolulu |
| Hawaii |
| United States |
| Kahului | Hawaii | United States |
| Waipahu | Hawaii | United States |
| ‘Aiea | Hawaii | United States |
| New York | New York | United States |
| Houston | Texas | United States |
| NOT COMPLETED |
|
|
Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Test | Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study. |
|
|
| Primary | Overall Vision | Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120. | Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations. | Posted | Mean | Standard Deviation | units on a scale | 1- week Follow-up |
|
|
|
| Primary | Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim | LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision. | Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol. | Posted | Mean | Standard Deviation | LogMar | 1-week follow-up | Eyes | Eyes |
|
|
|
| Primary | Monocular logMar Visual Acuity - Standard Low Contrast Bright | LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision. | Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations. | Posted | Mean | Standard Deviation | LogMar | 1- week Follow-up | Eyes | Eyes |
|
|
|
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Test | Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study. | 0 | 113 | 0 | 113 |
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