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The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.
Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period will be 2 hours. |
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| Sequence 2 | Other | Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period will be 2 hours. |
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| Sequence 3 | Other | LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period will be 2 hours. |
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| Sequence 4 | Other | PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period will be 2 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LID018869+RepleniSH | Device | Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Percent Area of Corneal Staining | A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting. | Hour 2 (each wear period) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 6565 | Maitland | Florida | 32751 | United States |
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This reporting group includes all enrolled subjects.
Subjects were recruited from one investigative site located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours. |
| FG001 | Sequence 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (2 Hours) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2021 | Apr 1, 2022 |
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| LID018869+Biotrue | Device | Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue) |
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| Biofinity+RepleniSH | Device | Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH) |
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| PV+Biotrue | Device | Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue) |
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Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was be 2 hours. |
| FG002 | Sequence 3 | LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours. |
| FG003 | Sequence 4 | PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours. |
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| NOT COMPLETED |
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| Washout (Day of & Day Prior to Visit 3) |
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| Second Wear Period (2 Hours) |
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Safety Analysis Set: All subjects/eyes exposed to any study lens, whether or not presoaked in the study multi-purpose disinfecting solution (MPDS)
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours. |
| BG001 | Sequence 2 | Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was 2 hours. |
| BG002 | Sequence 3 | LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours. |
| BG003 | Sequence 4 | PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours. |
| BG004 | 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 | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Average Percent Area of Corneal Staining | A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting. | Safety Analysis Set | Posted | Mean | Standard Deviation | percentage of area | Hour 2 (each wear period) | eyes | eyes |
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Adverse events (AE's) were collected from time of consent to study exit, approximately 1 week.
An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of pretreatment and non-ocular AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
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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 | Pretreatment | Events reported in this group occurred prior to exposure to the study contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG001 | LID018869+RepleniSH Ocular | Events reported in this group occurred while exposed to the study contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | Biofinity+RepleniSH Ocular | Events reported in this group occurred while exposed to the study contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG003 | LID018869+Biotrue Ocular | Events reported in this group occurred while exposed to the study contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG004 | PV+Biotrue Ocular | Events reported in this group occurred while exposed to the study contact lenses | 0 | 36 | 0 | 36 | 0 | 36 |
| EG005 | All Nonocular | Events reported in this group occurred while left and right eyes were exposed to different study lenses as per randomized regimen sequence | 0 | 36 | 0 | 36 | 0 | 36 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2021 | Apr 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| eyes |
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