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The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synergi, then Biotrue, then OTE | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
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| Synergi, then OTE, then Biotrue | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
|
| Biotrue, then OTE, then Synergi | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
|
| Biotrue, then Synergi, then OTE | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotrue multipurpose solution | Device | Contact lens care solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ex Vivo Contact Angle | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort | Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged. | 8 hours |
| Corneal Staining Type |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were recruited and enrolled from one Canadian study center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synergi, Then Biotrue, Then OTE | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| FG001 | Synergi, Then OTE, Then Biotrue | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| FG002 | Biotrue, Then OTE, Then Synergi | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| FG003 | Biotrue, Then Synergi, Then OTE | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| FG004 | OTE, Then Biotrue, Then Synergi | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| FG005 | OTE, Then Synergi, Then Biotrue | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, 8 Hours |
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| Period 2, 8 Hours |
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| Period 3, 8 Hours |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled participants |
| 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 |
| 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 | Ex Vivo Contact Angle | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens. | This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error. | Posted | Mean | Standard Deviation | degrees | 8 hours |
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Adverse events were collected for the duration of the trial: 24-NOV-2010 to 8-FEB-2011.
This reporting group includes all enrolled and exposed participants
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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 | Synergi | Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Alcon Research, Ltd. | 888.451.3937 | medinfo@alconlabs.com |
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| OTE, then Biotrue, then Synergi | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
|
| OTE, then Synergi, then Biotrue | Other | Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period. |
|
| Sauflon Synergi multipurpose solution | Device | Contact lens care solution |
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| OTE Elements multipurpose solution | Device | Contact lens care solution |
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| Silicone hydrogel contact lenses (Acuvue Advance) | Device | Commercially marketed contact lenses |
|
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Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.
| 8 hours |
| Corneal Staining Extent | Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged. | 8 hours |
| COMPLETED |
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| COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
| OG002 | OTE Elements | Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours. |
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| Secondary | Subjective Comfort | Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged. | This reporting group includes all participants who completed the study. | Posted | Mean | Standard Deviation | Units on a scale | 8 hours |
|
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| Secondary | Corneal Staining Type | Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged. | This reporting group includes all participants who completed the study. | Posted | Mean | Standard Deviation | Units on a scale | 8 hours |
|
|
|
| Secondary | Corneal Staining Extent | Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged. | This reporting group includes all participants who completed the study. | Posted | Mean | Standard Deviation | percentage of cornea | 8 hours |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Bio-True | Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours. | 0 | 21 | 0 | 21 |
| EG002 | OTE Elements | Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours. | 0 | 20 | 0 | 20 |
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