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The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1/Spectacles/Test 2/Test 3 | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 1 (etafilcon A with Lacreon), spectacles, TEST 2 (etafilcon A with Lacreon with print) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours. |
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| Test 2/Test 3/ Spectacles/Test 1 | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 2 (etafilcon A with Lacreon with print), TEST 3 (etafilcon A with print), spectacles and TEST 1 (etafilcon A with Lacreon) in both eyes for 8 +/-1 hours. |
|
| Test 3/Test 1/ Test 2/ Spectacles | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 3 (etafilcon A with print), TEST 1 (etafilcon A with Lacreon), TEST 2 (etafilcon A with Lacreon with print) and spectacles in both eyes for 8 +/-1 hours. |
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| Spectacles/Test 2/Test 1/Test 3 | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as spectacles, TEST 2 (etafilcon A with Lacreon with print), TEST 1 (etafilcon A with Lacreon) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A with Lacreon | Device | contact lens with Lacreon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100. | 8 hours post fit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waterloo | Ontario | Canada |
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A total of 39 subjects were enrolled in this study. Of those enrolled subjects 15 subjects did not meet the eligibility criteria. The remaining 24 subjects were successfully dispensed a study lens and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 1/Spectacle/Test 2/ Test 3 | Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print). |
| FG001 | Test 2/ Test 3/ Spectacle/ Test 1 | Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron). |
| FG002 | Test 3/ Test 1/ Test 2/ Spectacle | Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle. |
| FG003 | Spectacle/ Test 2/ Test 1/ Test 3 | Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All subjects that were dispensed a study lens. |
| 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 | Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100. | Analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | percentage of change from baseline | 8 hours post fit |
|
Entire duration of study (approximately 4 Months)
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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 | Spectacle | Subjects wore spectacles in any of the 4 periods of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Osborn Lorenz, OD, MS | Johnson & Johnson Vision Care Inc. | 614 459-9477 | KOSBORN@its.jnj.com |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| etafilcon A with Lacreon with print | Device | contact lens with Lacreon and cosmetic print |
|
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| etafilcon A with print | Device | contact lens with print |
|
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| Spectacles (habitual) | Device | Spectacles |
|
| 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 | Number | participants |
|
Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
| OG001 | Test 2 (Etafilcon A With Lacreon With Print) | Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study. |
| OG002 | Test 3 (Etafilcon A With Print) | Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study. |
| OG003 | Spectacle | Subjects that wore spectacles in any of the 4 periods of this study. |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Test 1 (Etafilcon A With Lacreon) | Subjects received Test 1 (etafilcon A with Lacreon) in any of the 4 periods of this study. | 0 | 24 | 0 | 24 |
| EG002 | Test 2 (Etafilcon A With Lacreon With Print) | Subjects received Test 2 (etafilcon A with Lacreon with print) in any of the 4 periods of this study. | 0 | 24 | 0 | 24 |
| EG003 | Test 3 (Etafilcon A With Print) | Subjects received Test 3 (etafilcon A with print) in any of the 4 periods of this study. | 0 | 24 | 0 | 24 |
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