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This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Multi-Purpose Solution | Experimental | contact lens care solution |
|
| ReNu MultiPlus Multi-Purpose Solution | Active Comparator | contact lens care solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vistakon Investigational Multi-Purpose Solution II | Device | contact lens care solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings (SLF) | Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported. | Up to 3 months Post Lens Wear |
| Distance Visual Acuity (LogMAR) | Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported. | Up to 3 Months Post Lens Wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mission Viejo | California | United States | ||||
Allocation of subjects to the 5 contact lenses was fairly balanced ranging from 57 to 61 subjects per lens, while the allocation of subjects to solution was 2:1 for the test and control solution respectively.
A total of 315 subjects were enrolled in this study. Of the enrolled subjects 20 did not meet the eligibility criteria and 295 subjects were randomized to treatment.Of the randomized subjects 16 were discontinued from the study, while 279 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solution1 (Etafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| FG001 | Solution1 (Comfilcon A) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ReNu MultiPlus Multi-Purpose Solution | Device | contact lens care solution |
|
| Orlando |
| Florida |
| United States |
| Tallahassee | Florida | United States |
| Bloomington | Illinois | United States |
| Pittsburg | Kansas | United States |
| Jamestown | New York | United States |
| Vestal | New York | United States |
| Athens | Ohio | United States |
| Moon Township | Pennsylvania | United States |
| State College | Pennsylvania | United States |
| Amarillo | Texas | United States |
| Katy | Texas | United States |
| Salt Lake City | Utah | United States |
| Charlottesville | Virginia | United States |
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| FG002 | Solution1 (Balafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| FG003 | Solution1 (Lotrafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| FG004 | Solution1 (Galyfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| FG005 | Solution2 (Etafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| FG006 | Solution2 (Comfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| FG007 | Solution2 (Balafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| FG008 | Solution2 (Lotrafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| FG009 | Solution2 (Galyfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
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| NOT COMPLETED |
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All subjects that were dispensed a study lens and solution.
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| ID | Title | Description |
|---|---|---|
| BG000 | Solution 1 (Etafilcon A) | All subjects that were dispensed solution 1 and the etafilcon A lens. |
| BG001 | Solution 1 (Comfilcon A) | All subjects that were dispensed solution 1 and the comfilcon A study lens. |
| BG002 | Solution 1 (Balafilcon A) | All subjects that were dispensed solution 1 and the balafilcon A study lens. |
| BG003 | Solution 1 (Lotrafilcon A) | All subjects that were dispensed solution 1 and the lotrafilcon A study lens. |
| BG004 | Solution 1 (Galyfilcon A) | All subjects that were dispensed solution 1 and the galyfilcon A study lens. |
| BG005 | Solution 2 (Etafilcon A) | All subjects that were dispensed solution 2 and etafilcon A study lens. |
| BG006 | Solution 2 (Comfilcon A) | All subjects that were dispensed solution 2 and the comfilcon A study lens. |
| BG007 | Solution 2 (Balafilcon A) | All subjects that were dispensed solution 2 and balafilcon A study lens. |
| BG008 | Solution 2 (Lotrafilcon A) | All subjects that were dispensed solution 2 and the lotrafilcon A study lens. |
| BG009 | Solution 2 (Galyfilcon A) | All subjects that were dispensed solution 2 and the galyfilcon A study lens. |
| BG010 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Slit Lamp Findings (SLF) | Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported. | All subjects that completed the study. | Posted | Number | eyes (2 per subject) | Up to 3 months Post Lens Wear | Subject eyes | Subject eyes |
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| Primary | Distance Visual Acuity (LogMAR) | Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported. | All subjects that completed the study. | Posted | Mean | Standard Deviation | LogMAR | Up to 3 Months Post Lens Wear | Subjects Eyes | Subjects Eyes |
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Throughout the duration of the study. Approximately 3 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 | Solution1 (Etafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. | 0 | 40 | 0 | 40 | ||
| EG001 | Solution1 (Comfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. | 0 | 40 | 0 | 40 | ||
| EG002 | Solution1 (Balafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. | 0 | 38 | 0 | 38 | ||
| EG003 | Solution1 (Lotrafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. | 1 | 40 | 0 | 40 | ||
| EG004 | Solution1 (Galyfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. | 0 | 41 | 2 | 41 | ||
| EG005 | Solution2 (Etafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. | 0 | 18 | 0 | 18 | ||
| EG006 | Solution2 (Comfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. | 0 | 19 | 1 | 19 | ||
| EG007 | Solution2 (Balafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. | 0 | 19 | 1 | 19 | ||
| EG008 | Solution2 (Lotrafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. | 0 | 20 | 0 | 20 | ||
| EG009 | Solution2 (Galyfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. | 0 | 20 | 1 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous Hemorrhage / Retinal Detachment | Eye disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis - Bacterial | Eye disorders |
| |||
| Symptoms/ Complaints | Eye disorders | Symptoms and complaints requiring treatment. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristy Canavan, O.D.- PRINCIPAL RESEARCH OPTOMETRIST, Clin Ops | Johson & Johnson Vision Care Inc. | 904-443-3500 | KCANAVA2@its.jnj.com |
| Male |
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| Subject eyes |
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| Corneal Neovascularization |
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| Corneal Staining |
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| Injection |
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| Tarsal Abnormalities |
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| Other Findings |
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Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| OG004 | Solution1 (Galyfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution. |
| OG005 | Solution2 (Etafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| OG006 | Solution2 (Comfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| OG007 | Solution2 (Balafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| OG008 | Solution2 (Lotrafilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
| OG009 | Solution2 (Galyfilcon A) | Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution. |
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