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The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| galyfilcon A prototype lens/enfilcon A lens | Other | galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second. |
|
| enfilcon A lens/galyfilcon A prototype lens | Other | enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyfilcon A prototype lens | Device | Prototype silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Visual Acuity Assessment | Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale. | Post lens insertion (baseline) |
| Binocular Visual Acuity | Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results | Post lens insertion (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Limbal Redness of Grade 3 or Above | Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. | After 6-8 days of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pismo Beach | California | United States | ||||
There were 39 enrolled, with one screen failure prior to randomization, leaving 38 starting and completing the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A Prototype Lens/Enfilcon A Lens | The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second. |
| FG001 | Enfilcon A Lens/Galyfilcon A Prototype Lens | The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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Baseline summary was conducted on all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who enrolled in the study. |
| 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 | Monocular Visual Acuity Assessment | Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale. | Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study. | Posted | Least Squares Mean | Standard Error | logMAR | Post lens insertion (baseline) | eyes | eyes |
|
Adverse events were recorded when the subjects were exposed to the Investigational lenses.
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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 | All Subjects | All subjects who exposed to the Investigation lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D., M.S. F.A.A.O. Principal Research Optometrist | Johnson and Johnson Vision Care | 1 904 443-1290 | bpall@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| enfilcon A lens | Device | Marketed silicone hydrogel contact lens |
|
|
| Bulbar Redness of Grade 3 or Above |
Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. |
| After 6-8 days of lens wear |
| Warwick |
| Rhode Island |
| United States |
| Fincastle | Virginia | United States |
| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| eyes |
|
|
|
| Secondary | Limbal Redness of Grade 3 or Above | Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. | Analysis was conducted on subjects who successfully completed the study. | Posted | Number | Subject Eyes | After 6-8 days of lens wear | Eyes | Eyes |
|
|
|
| Secondary | Bulbar Redness of Grade 3 or Above | Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. | Analysis was conducted on subjects who successfully completed the study. | Posted | Number | Subject Eyes | After 6-8 days of lens wear | Eyes | Eyes |
|
|
|
| Primary | Binocular Visual Acuity | Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results | Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol. | Posted | Least Squares Mean | Standard Error | LogMAR | Post lens insertion (baseline) |
|
|
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|
| 0 |
| 38 |
| 0 |
| 38 |
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