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This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula ("COMPLETE Multi-Purpose Solution") when used by participants who are habitual contact lens wearers.
Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT12 Multi-Purpose Solution | Experimental | Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. |
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| COMPLETE Multi-Purpose Solution | Active Comparator | Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT12 Multi-Purpose Solution | Device | Contact lens cleaning and disinfecting solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. | Month 3 |
| Eye Dryness | Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. | Month 3 |
| Degree Of Lens Deposits | Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy. | Month 3 |
| Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings | Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment. Grades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe) | Day 0 (post-dispensing) through Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 1 | Birmingham | Alabama | 35216 | United States | ||
| Bausch Site 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40216672 | Derived | Schaeffer M, Shahidi A, Mosehauer G, Rah M, Reindel W. Clinical Evaluation of Biotrue Hydration Plus Multipurpose Solution in Daily Use with Planned Replacement Soft Contact Lenses. Ophthalmol Ther. 2025 Jun;14(6):1249-1260. doi: 10.1007/s40123-025-01123-0. Epub 2025 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT12 Multi-Purpose Solution | Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. ABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution Sensitive Eyes® Rewetting Drops: For use as needed during the study. |
| 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 | Feb 13, 2019 |
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| COMPLETE Multi-Purpose Solution | Device | Contact lens cleaning and disinfecting solution |
|
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| Sensitive Eyes® Rewetting Drops | Device | For use as needed during the study. |
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| San Diego |
| California |
| 92123 |
| United States |
| Bausch Site 3 | San Francisco | California | 94112 | United States |
| Bausch Site 4 | Denver | Colorado | 80246 | United States |
| Bausch Site 5 | Sarasota | Florida | 34232 | United States |
| Bausch Site 6 | Decatur | Georgia | 30035 | United States |
| Bausch Site 7 | Bloomington | Illinois | 61701 | United States |
| Bausch Site 9 | Leavenworth | Kansas | 66048 | United States |
| Bausch Site 8 | Pittsburg | Kansas | 66762 | United States |
| Bausch Site 10 | Portland | Maine | 04101 | United States |
| Bausch Site 11 | East Lansing | Michigan | 48823 | United States |
| Bausch Site 12 | St Louis | Missouri | 63144 | United States |
| Bausch Site 13 | Jamestown | New York | 14701 | United States |
| Bausch Site 14 | Vestal | New York | 13850 | United States |
| Bausch Site 15 | State College | Pennsylvania | 16801 | United States |
| Bausch Site 17 | Brentwood | Tennessee | 37027 | United States |
| Bausch Site 16 | Nashville | Tennessee | 37205 | United States |
| FG001 |
| COMPLETE Multi-Purpose Solution |
Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. COMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution Sensitive Eyes® Rewetting Drops: For use as needed during the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT12 Multi-Purpose Solution | Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. ABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution Sensitive Eyes® Rewetting Drops: For use as needed during the study. |
| BG001 | COMPLETE Multi-Purpose Solution | Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. COMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution Sensitive Eyes® Rewetting Drops: For use as needed during the study. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 Comfort | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. | Randomized participants who attended the 3-month visit and did not have major protocol deviations | Posted | Mean | Standard Deviation | score on a scale | Month 3 | Eyes | Eyes |
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| Primary | Eye Dryness | Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. | Randomized participants who attended the 3-month visit and did not have major protocol deviations | Posted | Mean | Standard Deviation | score on a scale | Month 3 | Eyes | Eyes |
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| Primary | Degree Of Lens Deposits | Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy. | Randomized participants who attended the 3-month visit and did not have major protocol deviations | Posted | Count of Units | Eyes | Month 3 | Eyes | Eyes |
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| Primary | Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings | Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment. Grades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe) | Posted | Count of Participants | Participants | Day 0 (post-dispensing) through Month 3 |
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3 months
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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 | ABT12 Multi-Purpose Solution | Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. ABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution Sensitive Eyes® Rewetting Drops: For use as needed during the study. | 0 | 127 | 0 | 127 | 0 | 127 |
| EG001 | COMPLETE Multi-Purpose Solution | Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. COMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution Sensitive Eyes® Rewetting Drops: For use as needed during the study. | 0 | 125 | 0 | 125 | 0 | 125 |
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Please contact sponsor for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Bausch & Lomb | 9089271162 | Johnson.Varughese@bauschhealth.com |
| May 4, 2022 |
| Prot_SAP_000.pdf |
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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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| Participants |
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