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The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL-300-PFM04 | Experimental |
| |
| Lubricating and rewetting drops | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-300-PFM04 | Device | Preservative Free Lubricating and Rewetting Drops for use during contact lens wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Averaged Over All Follow-up Visits | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits. | 1 month |
| Dryness Averaged Over All Follow-up Visits | Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits. | 1 month |
| Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit | At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present). | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 108 | San Francisco | California | 94112 | United States | ||
| Bausch Site 111 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BL-300-PFM04 | BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear |
| FG001 | Lubricating and Rewetting Drops | OPTI-FREE: Replenish Rewetting Drops |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2019 |
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| OPTI-FREE | Device | Replenish Rewetting Drops |
|
| Torrance |
| California |
| 90503 |
| United States |
| Bausch Site 106 | Sarasota | Florida | 34237 | United States |
| Bausch Site 104 | Decatur | Georgia | 30035 | United States |
| Bausch Site 110 | Bloomington | Kansas | 61704 | United States |
| Bausch Site 112 | Leavenworth | Kansas | 66048 | United States |
| Bausch Site 107 | Portland | Maine | 04101 | United States |
| Bausch Site 109 | Edina | Minnesota | 55436 | United States |
| Bausch Site 102 | Jamestown | New York | 14701 | United States |
| Bausch Site 113 | Vestal | New York | 13850 | United States |
| Bausch Site 101 | Miamisburg | Ohio | 45342 | United States |
| Bausch Site 105 | West Chester | Ohio | 45069 | United States |
| Bausch Site 114 | Grants Pass | Oregon | 97526 | United States |
| Bausch Site 115 | Brentwood | Tennessee | 37027 | United States |
| Bausch Site 103 | Nashville | Tennessee | 37205 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BL-300-PFM04 | BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear |
| BG001 | Lubricating and Rewetting Drops | OPTI-FREE: Replenish Rewetting Drops |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Overall Comfort Averaged Over All Follow-up Visits | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits. | Posted | Mean | Standard Deviation | units on a scale | 1 month | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||||
| Primary | Dryness Averaged Over All Follow-up Visits | Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits. | Posted | Mean | Standard Deviation | units on a scale | 1 month | Eyes | Eyes |
|
| ||||||||||||||||||||||||||||||
| Primary | Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit | At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present). | Posted | Count of Units | Eyes | 1 month | Eyes | Eyes |
|
|
1 Month
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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 | BL-300-PFM04 | BL-300-PFM04: Preservative Free Lubricating and Rewetting Drops for use during contact lens wear | 0 | 188 | 0 | 188 | 0 | 188 |
| EG001 | Lubricating and Rewetting Drops | OPTI-FREE: Replenish Rewetting Drops | 0 | 181 | 0 | 181 | 0 | 181 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Trials | Bausch + Lomb Incorporated | (585) 623-9588 | Margaret.Swartzenberg@bausch.com |
| Aug 31, 2023 |
| Prot_SAP_000.pdf |
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| >=65 years |
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| Male |
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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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| Eyes |
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