Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution (NCT NCT05565937)
NCT ID: NCT05565937
Last Updated: 2025-05-20
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
295 participants
Primary outcome timeframe
Assessed at all follow-up visits through 3 months.
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
BL-3100-NBR03
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
152
|
|
Overall Study
COMPLETED
|
140
|
147
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
BL-3100-NBR03
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Persistent study-related symptoms /complaints
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
2
|
|
Overall Study
Anisometropia
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
Baseline characteristics by cohort
| Measure |
BL-3100-NBR03
n=143 Participants
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
n=152 Participants
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 10.26 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 9.84 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
143 participants
n=5 Participants
|
152 participants
n=7 Participants
|
295 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at all follow-up visits through 3 months.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 |
BL-3100-NBR03
n=286 Eyes
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
n=304 Eyes
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
Overall Comfort Averaged Over All Follow-up Visits
|
91.7 score on a scale
Standard Deviation 9.99
|
90.7 score on a scale
Standard Deviation 10.83
|
PRIMARY outcome
Timeframe: Assessed at all follow-up visits through 3 months.Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
Outcome measures
| Measure |
BL-3100-NBR03
n=286 Eyes
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
n=304 Eyes
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
Vision Averaged Over All Follow-up Visits
|
95.5 score on a scale
Standard Deviation 6.69
|
94.3 score on a scale
Standard Deviation 7.75
|
PRIMARY outcome
Timeframe: Assessed at all follow-up visits through 3 months.Population: All randomized subjects with at least one non-missing values for front surface deposit grading. Two subjects (4 eyes) in the BL-3100-NBR03 arm and 1 subject (2 eyes) in the renu Advanced Formula arm with no front surface grading measurements reported were excluded from this analysis.
The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected.
Outcome measures
| Measure |
BL-3100-NBR03
n=282 Eyes
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
n=302 Eyes
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
The Percentage of Eyes with Front Surface Deposits Grade of <= 2
|
99.3 percentage of eyes
|
97.7 percentage of eyes
|
|
The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
The Percentage of Eyes with Front Surface Deposits Grade of >2
|
0.7 percentage of eyes
|
2.3 percentage of eyes
|
PRIMARY outcome
Timeframe: Assessed at 3 monthsGraded slit-lamp findings will be assessed for each eye using Grades 0 through 4.
Outcome measures
| Measure |
BL-3100-NBR03
n=282 Eyes
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
n=302 Eyes
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
Present
|
0 percentage of eyes
|
0.7 percentage of eyes
|
|
The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
Absent
|
100 percentage of eyes
|
99.3 percentage of eyes
|
Adverse Events
BL-3100-NBR03
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Renu® Advanced Formula
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BL-3100-NBR03
n=143 participants at risk
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
|
Renu® Advanced Formula
n=151 participants at risk
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/143 • AE data collected over all scheduled follow-up visits approximately 3 months
|
0.66%
1/151 • AE data collected over all scheduled follow-up visits approximately 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place