Trial Outcomes & Findings for Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations (NCT NCT04789382)
NCT ID: NCT04789382
Last Updated: 2022-05-25
Results Overview
A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Hour 2 (each wear period)
Results posted on
2022-05-25
Participant Flow
Subjects were recruited from one investigative site located in the United States.
This reporting group includes all enrolled subjects.
Participant milestones
| Measure |
Sequence 1
LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours.
|
Sequence 2
Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was be 2 hours.
|
Sequence 3
LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours.
|
Sequence 4
PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours.
|
|---|---|---|---|---|
|
First Wear Period (2 Hours)
STARTED
|
9
|
9
|
9
|
9
|
|
First Wear Period (2 Hours)
COMPLETED
|
9
|
9
|
9
|
9
|
|
First Wear Period (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (Day of & Day Prior to Visit 3)
STARTED
|
9
|
9
|
9
|
9
|
|
Washout (Day of & Day Prior to Visit 3)
COMPLETED
|
9
|
9
|
9
|
9
|
|
Washout (Day of & Day Prior to Visit 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Wear Period (2 Hours)
STARTED
|
9
|
9
|
9
|
9
|
|
Second Wear Period (2 Hours)
COMPLETED
|
9
|
9
|
9
|
9
|
|
Second Wear Period (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Baseline characteristics by cohort
| Measure |
Sequence 1
n=9 Participants
LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period was 2 hours.
|
Sequence 2
n=9 Participants
Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period was 2 hours.
|
Sequence 3
n=9 Participants
LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period was 2 hours.
|
Sequence 4
n=9 Participants
PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period was 2 hours.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
29.0 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
36.0 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
31.6 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 6.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
9 participants
n=7 Participants
|
36 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Hour 2 (each wear period)Population: Safety Analysis Set
A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
Outcome measures
| Measure |
LID018869+RepleniSH
n=36 eyes
LID018869+RepleniSH worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
|
Biofinity+RepleniSH
n=36 eyes
Biofinity+RepleniSH worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
|
LID018869+Biotrue
n=36 eyes
LID018869+Biotrue worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
|
PV+Biotrue
n=36 eyes
PV+Biotrue worn for 2 hours in the right eye or left eye and during Period 1 or Period 2, as randomized
|
|---|---|---|---|---|
|
Average Percent Area of Corneal Staining
|
2.93 percentage of area
Standard Deviation 8.86
|
0.45 percentage of area
Standard Deviation 1.03
|
6.06 percentage of area
Standard Deviation 14.75
|
3.52 percentage of area
Standard Deviation 11.87
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID018869+RepleniSH Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofinity+RepleniSH Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID018869+Biotrue Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PV+Biotrue Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Nonocular
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 Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER