Sponsor study identifier
interventional
252
1 country
17
Study Start
March 8, 2019
Actual (reported)Primary Completion
August 1, 2019
Actual (reported)Study Completion
August 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2019
Actual (reported)March 29, 2019
Actual (reported)April 1, 2019
Actual (reported)August 1, 2019
Actual (reported)August 1, 2019
Actual (reported)November 30, 2022
Actual (reported)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
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.
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.
Contact lens cleaning and disinfecting solution
Contact lens cleaning and disinfecting solution
Bausch Site 1
Birmingham, Alabama, 35216, United States
Bausch Site 2
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
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.
Johnson Varughese
Bausch & Lomb Incorporated
252 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2019
First Posted
April 1, 2019
Study Start
March 8, 2019
Actual (reported)A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens
Vistakon Investigational Multi-purpose Contact Lens Care Solution.
For use as needed during the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
August 1, 2019
Actual (reported)Study Completion
August 1, 2019
Actual (reported)Last Updated
March 3, 2023
Results First Posted
November 30, 2022
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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