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The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A contact lens | Active Comparator | ACUVUE OASYS |
|
| lotrafilcon A contact lens | Active Comparator | NIGHT&DAY |
|
| lotrafilcon B contact lens | Active Comparator | O2Optix |
|
| balafilcon A contact lens | Active Comparator | PureVision |
|
| comfilcon A contact lens | Active Comparator | Biofinity |
|
| etafilcon A contact lens | Active Comparator | ACUVUE 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | 1 week extended wear contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Corneal Infiltrative Events | Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. | 52 weeks |
| Incidence of Adverse Events | Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Research Foundation | Chennai | Tamil Nadu | 600 006 | India |
There were 350 subjects recruited with 314 subjects being dispensed lenses. These 36 subjects were excluded due to failing to meet inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Contact Lens | ACUVUE OASYS |
| FG001 | Lotrafilcon A Contact Lens | NIGHT&DAY |
| FG002 | Lotrafilcon B Contact Lens | O2Optix |
| FG003 | Balafilcon A Contact Lens | PureVision |
| FG004 | Comfilcon A Contact Lens | Biofinity |
| FG005 | Etafilcon A Contact Lens | ACUVUE 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon A Contact Lens | ACUVUE OASYS |
| BG001 | Lotrafilcon A Contact Lens | NIGHT&DAY |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data was collected on those subjects 18 years and older, there were no pediatric patients enrolled in the study. |
| 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 | Incidence of Corneal Infiltrative Events | Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. | Subjects who were enrolled and dispensed lenses. | Posted | Number | 95% Confidence Interval | percentage of participants | 52 weeks |
|
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Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.
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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 | Senofilcon A Contact Lens | ACUVUE OASYS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microbial Keratitis | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CLPU | Eye disorders | Systematic Assessment | CLPU = Contact Lens Peripheral Ulcer; significant adverse event |
Cautions for results: low completed enrollment numbers and number of non-neophytes lower than required per protocol. Arms not gender matched; Proportion of neophytes/non-neophytes not balanced; High rate of drop-out among subjects enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist | Vistakon | 1 904 443-1032 | kosborn@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon A |
| Device |
1 week extended wear contact lens |
|
| lotrafilcon B | Device | 1 week extended wear contact lens |
|
| balafilcon A | Device | 1 week extended wear contact lens |
|
| comfilcon A | Device | 1 week extended wear contact lens |
|
| etafilcon A | Device | 1 week extended wear contact lens |
|
| BG002 |
| Lotrafilcon B Contact Lens |
O2Optix |
| BG003 | Balafilcon A Contact Lens | PureVision |
| BG004 | Comfilcon A Contact Lens | Biofinity |
| BG005 | Etafilcon A Contact Lens | ACUVUE 2 |
| BG006 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lotrafilcon B Contact Lens |
O2Optix |
| OG003 | Balafilcon A Contact Lens | PureVision |
| OG004 | Comfilcon A Contact Lens | Biofinity |
| OG005 | Etafilcon A Contact Lens | ACUVUE 2 |
|
|
| Primary | Incidence of Adverse Events | Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type. | Subjects who were enrolled and dispensed lenses. | Posted | Number | 95% Confidence Interval | percentage of participants | 52 weeks |
|
|
|
| 1 |
| 55 |
| 27 |
| 55 |
| EG001 | Lotrafilcon A Contact Lens | NIGHT&DAY | 0 | 58 | 17 | 58 |
| EG002 | Lotrafilcon B Contact Lens | O2Optix | 0 | 42 | 10 | 42 |
| EG003 | Balafilcon A Contact Lens | PureVision | 0 | 64 | 23 | 64 |
| EG004 | Comfilcon A Contact Lens | Biofinity | 1 | 43 | 18 | 43 |
| EG005 | Etafilcon A Contact Lens | ACUVUE 2 | 0 | 52 | 8 | 52 |
|
| SIE | Eye disorders | Systematic Assessment | SIE = Significant Infiltrative Event; significant adverse event |
|
| New Corneal Scar | Eye disorders | Systematic Assessment | New corneal scar without positive history; significant adverse events |
|
| Other Significant | Eye disorders | Systematic Assessment | Not specifically identified due to low counts of individual events |
|
| SLF Grade 2 or Less requiring Treatment | Eye disorders | Systematic Assessment | Slit lamp finding of Grade 1 or 2 (on 0-4 scale) |
|
| Other Non-significant | Eye disorders | Systematic Assessment | Not specifically identified due to low counts of individual events |
|
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