Trial Outcomes & Findings for Comparing the Performance of 1 Day Multifocal Contact Lenses (NCT NCT04449263)
NCT ID: NCT04449263
Last Updated: 2021-06-22
Results Overview
Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
COMPLETED
NA
60 participants
Day 13
2021-06-22
Participant Flow
60 subjects were enrolled and 1 subject discontinued because of screen failure prior to dispense of their habitual lenses.
All 59 subjects wore their habitual lenses for two weeks prior to randomization to test lens and control lens.
Participant milestones
| Measure |
Lens A (Test) Then Lens B (Control)
Subjects wore their habitual lenses for 2 weeks and were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Contact lens: Habitual Lenses Contact Lens: Test Lens A Contact Lens: Control Lens B
|
Lens B (Control) Then Lens A (Test)
All Subjects wore their habitual lenses for 2 weeks prior to randomization and were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Contact Lens: Habitual lenses
Contact lens: Control Lens B
Contact Lens : Test lens A
|
|---|---|---|
|
First Intervention
STARTED
|
29
|
30
|
|
First Intervention
COMPLETED
|
29
|
30
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
29
|
30
|
|
Second Intervention
COMPLETED
|
29
|
30
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
|
Third Intervention
STARTED
|
29
|
30
|
|
Third Intervention
COMPLETED
|
29
|
30
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=59 Participants
Subjects wore their habitual lenses for two weeks and then randomized to wear Test lens A and Control Lens B for 2 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=59 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=59 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=59 Participants
|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 7.3 • n=59 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=59 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=59 Participants
|
PRIMARY outcome
Timeframe: Day 13Population: One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only.
Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
Outcome measures
| Measure |
Subjects Habitual Lenses
n=58 Participants
Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Contact Lenses: Habitual Lenses
|
Lens A (Test)
n=58 Participants
Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Contact Lens: Test Lens A
|
Lens B (Control)
n=57 Participants
Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Contact lens: Control Lens B
|
|---|---|---|---|
|
Subjective At-home Ratings for Ease of Lens Handling for Insertion
|
8.90 units on a scale
Standard Deviation 1.59
|
8.28 units on a scale
Standard Deviation 2.10
|
9.18 units on a scale
Standard Deviation 1.12
|
Adverse Events
Subjects Habitual Lenses
Lens A (Test)
Lens B (Control)
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
- Publication restrictions are in place