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The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| galyfilcon A | Other | Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. |
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| lotrafilcon B | Other | Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. |
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| comfilcon A | Other | Subjects that were randomized to wear comfilcon A lens throughout the course of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyfilcon A, BC 8.30 | Device | galyfilcon A, BC 8.30 soft contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Subjective Comfort | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes 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 indicate a more favorable/positive response. | after 2 weeks of contact lens wear |
| Corneal Staining | Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated. | after 2 weeks of contact lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Subjective Lens Handling | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes 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 indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brea | California | 92891 | United States | |||
There were 20 subjects who did not meet the inclusion or did meet the exclusion criteria. There were 10 screen failures and 10 who wore spectacles to baseline visit invoking the exclusion criteria.
There were thirty-five sites recruited in the US. There were 540 subjects recruited with 520 enrolled and randomized. The study was a 2-week, randomized, single-masked (subjects), parallel arm, bilateral dispensing study. The subject group was expected to be representative of a cross-section of the population within the US contact lens market.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A | Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. |
| FG001 | Lotrafilcon B | Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Baseline to 1-week Visit) |
|
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| lotrafilcon B, BC 8.60 |
| Device |
lotrafilcon B, BC 8.60 soft contact lens |
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| comfilcon A, BC 8.60 | Device | comfilcon A, BC 8.60 soft contact lens |
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| after 2 weeks of contact lens wear |
| Campbell |
| California |
| 95008 |
| United States |
| Cupertino | California | 95014 | United States |
| Mission Viejo | California | 92691 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Bridgeport | Connecticut | 06610 | United States |
| Aventura | Florida | 33180 | United States |
| Jacksonville | Florida | 32256 | United States |
| Tallahassee | Florida | 32308 | United States |
| Tampa | Florida | 33625 | United States |
| Winter Park | Florida | 32792 | United States |
| Roswell | Georgia | 30076 | United States |
| Bloomington | Illinois | 61701 | United States |
| Mishawaka | Indiana | 46545 | United States |
| Pittsburg | Kansas | 66763 | United States |
| Boston | Massachusetts | 02114 | United States |
| Independence | Missouri | 64055 | United States |
| Raytown | Missouri | 64133 | United States |
| Closter | New Jersey | 07624 | United States |
| New York | New York | 10001 | United States |
| Raleigh | North Carolina | 27615 | United States |
| North Olmsted | Ohio | 44070 | United States |
| Powell | Ohio | 43065 | United States |
| Kittanning | Pennsylvania | 16201 | United States |
| Warwick | Rhode Island | 02888 | United States |
| Chamberlain | South Dakota | 57325 | United States |
| Bartlett | Tennessee | 38134 | United States |
| Brentwood | Tennessee | 37027 | United States |
| Memphis | Tennessee | 38119 | United States |
| Tyler | Texas | 75701 | United States |
| Tyler | Texas | 75703 | United States |
| Salt Lake City | Utah | 84106 | United States |
| Burlington | Vermont | 05401 | United States |
| Salem | Virginia | 24153 | United States |
| Virginia Beach | Virginia | 23455 | United States |
| FG002 | Comfilcon A | Subjects that were randomized to wear comfilcon A lens throughout the course of the study. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (1-week to 2-week Visit) |
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Population consists of those subjects who were enrolled and randomly assigned to a treatment arm AND who completed the study per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Galyfilcon A | Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. |
| BG001 | Lotrafilcon B | Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. |
| BG002 | Comfilcon A | Subjects that were randomized to wear comfilcon A lens throughout the course of the study. |
| BG003 | 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 |
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| Region of Enrollment | Count of Participants | 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 | Overall Subjective Comfort | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes 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 indicate a more favorable/positive response. | Analysis is on those subjects who completed the study (n=501). | Posted | Least Squares Mean | Standard Error | CLUE score | after 2 weeks of contact lens wear |
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| Primary | Corneal Staining | Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated. | Analysis is on those subjects who completed the study (n=501). | Posted | Number | percentage of eyes | after 2 weeks of contact lens wear | Eyes | Eyes |
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| Secondary | Overall Subjective Lens Handling | Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes 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 indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated. | Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol. | Posted | Least Squares Mean | Standard Error | CLUE score | after 2 weeks of contact 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 | Galyfilcon A | Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. | 0 | 170 | 0 | 170 | ||
| EG001 | Lotrafilcon B | Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. | 0 | 177 | 0 | 177 | ||
| EG002 | Comfilcon A | Subjects that were randomized to wear comfilcon A lens throughout the course of the study. | 0 | 173 | 0 | 173 |
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Publication required agreement and written authorization from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Osborn, OD | Johnson & Johnson Vision Care | 1-904-443-1032 | KOsborn@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lost to Follow-up |
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| Poor Comfort |
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| Male |
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| This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A <= -5. Ha: galyfilcon A- comfilcon A> -5. | Mixed Models Analysis | Alpha is adjusted to 1.3% based on a Sidak multiplicity correction. | Mean Difference (Final Values) | 0.42 | Standard Error of the Mean | 2.79 | 2-Sided | 97.4 | -5.96 | 6.79 | The direction of comparison is AAHP - BIO. | Non-Inferiority or Equivalence | The non-inferiority margin is set at -5. |
| Eyes |
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