Trial Outcomes & Findings for A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses (NCT NCT03897751)
NCT ID: NCT03897751
Last Updated: 2023-03-03
Results Overview
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Month 3
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
125
|
|
Overall Study
COMPLETED
|
121
|
119
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses
Baseline characteristics by cohort
| Measure |
ABT12 Multi-Purpose Solution
n=127 Participants
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.
|
COMPLETE Multi-Purpose Solution
n=125 Participants
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.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 9.72 • n=93 Participants
|
34.1 years
STANDARD_DEVIATION 9.79 • n=4 Participants
|
34.3 years
STANDARD_DEVIATION 9.74 • n=27 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Randomized participants who attended the 3-month visit and did not have major protocol deviations
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Outcome measures
| Measure |
ABT12 Multi-Purpose Solution
n=234 Eyes
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.
|
COMPLETE Multi-Purpose Solution
n=226 Eyes
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.
|
|---|---|---|
|
Overall Comfort
|
88.9 score on a scale
Standard Deviation 11.49
|
87.5 score on a scale
Standard Deviation 12.24
|
PRIMARY outcome
Timeframe: Month 3Population: Randomized participants who attended the 3-month visit and did not have major protocol deviations
Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Outcome measures
| Measure |
ABT12 Multi-Purpose Solution
n=234 Eyes
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.
|
COMPLETE Multi-Purpose Solution
n=226 Eyes
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.
|
|---|---|---|
|
Eye Dryness
|
84.2 score on a scale
Standard Deviation 15.15
|
83.1 score on a scale
Standard Deviation 14.99
|
PRIMARY outcome
Timeframe: Month 3Population: Randomized participants who attended the 3-month visit and did not have major protocol deviations
Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.
Outcome measures
| Measure |
ABT12 Multi-Purpose Solution
n=234 Eyes
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.
|
COMPLETE Multi-Purpose Solution
n=226 Eyes
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.
|
|---|---|---|
|
Degree Of Lens Deposits
None or Light
|
231 Eyes
|
222 Eyes
|
|
Degree Of Lens Deposits
Medium or Heavy
|
3 Eyes
|
4 Eyes
|
PRIMARY outcome
Timeframe: Day 0 (post-dispensing) through Month 3Graded 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)
Outcome measures
| Measure |
ABT12 Multi-Purpose Solution
n=127 Participants
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.
|
COMPLETE Multi-Purpose Solution
n=125 Participants
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.
|
|---|---|---|
|
Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings
|
0 Participants
|
1 Participants
|
Adverse Events
ABT12 Multi-Purpose Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COMPLETE Multi-Purpose Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER