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The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1/Control 1, then Control 2/Test 2 | Other | Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
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| Test 2/Control 2, then Control 1/Test 1 | Other | Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
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| Control 1/Test 1, then Test 2/Control 2 | Other | Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact lens with investigational coating 1 | Device | Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Percent Area of Solution-related 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. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting. | Day 1 after 2 hours of wear, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, Trial Management Operations | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Johns Creek | Georgia | 30097 | United States |
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All 33 subjects enrolled were randomized. This reporting group includes all randomized subjects (33).
Subjects were recruited from 1 study center located in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 1/Control 1, Then Control 2/Test 2 | Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
| FG001 | Test 2/Control 2, Then Control 1/Test 1 | Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
| FG002 | Control 1/Test 1, Then Test 2/Control 2 | Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
| FG003 | Control 2/Test 2, Then Test 1/Control 1 | Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 2 Hours of Wear |
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| Washout Period Between Lens Wear |
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| Period 2, Second 2 Hours of Wear |
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This analysis population includes all subjects exposed to any study lens (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2. |
| 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 | Average Percent Area of Solution-related 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. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting. | This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set). | Posted | Mean | Standard Deviation | percentage of area | Day 1 after 2 hours of wear, each product |
|
Baseline through study completion, approximately 8 days
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.
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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 | Test 1 | All subjects exposed to contact lens with investigational coating 1 during Period 1 or Period 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr CDMA Project Lead, GCRA - Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | Alcon.medinfo@alcon.com |
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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 | Dec 9, 2016 | Jan 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2017 | Jan 23, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Control 2/Test 2, then Test 1/Control 1 | Other | Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs. |
|
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| Balafilcon A contact lens | Device | Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS |
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| OPTI-FREE® RepleniSH® MPDS | Device | Multipurpose contact lens solution |
|
| Contact lens with investigational coating 2 | Device | Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| OG001 | Control 1 | Balafilcon A contact lens worn contralaterally to Test 1 for approximately 2 hours during Period 1 or Period 2 |
| OG002 | Test 2 | Contact lens with investigational coating 2 worn for approximately 2 hours during Period 1 or Period 2 |
| OG003 | Control 2 | Balafilcon A contact lens worn contralaterally to Test 2 for approximately 2 hours during Period 1 or Period 2 |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Test 2 | All subjects exposed to contact lens with investigational coating 2 during Period 1 or Period 2 | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | Control | All subjects exposed to balafilcon A contact lens during Period 1 or Period 2 | 0 | 33 | 0 | 33 | 0 | 33 |
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