Trial Outcomes & Findings for Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens (NCT NCT06046209)
NCT ID: NCT06046209
Last Updated: 2024-12-12
Results Overview
Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Immediately after lens application
Results posted on
2024-12-12
Participant Flow
Participant milestones
| Measure |
Control Lens, Then Test Lens
Participants wore the Control Lens for 90 minutes (Period 1), and then the Test Lens for 90 minutes (Period 2)
|
Test Lens, Then Control Lens
Participants wore the Test Lens for 90 minutes (Period 1), and then the Control Lens for 90 minutes (Period 2)
|
|---|---|---|
|
Period 1: First Intervention-90 Minutes
STARTED
|
15
|
15
|
|
Period 1: First Intervention-90 Minutes
COMPLETED
|
15
|
15
|
|
Period 1: First Intervention-90 Minutes
NOT COMPLETED
|
0
|
0
|
|
Period 2: Second Intervention-90 Minutes
STARTED
|
15
|
15
|
|
Period 2: Second Intervention-90 Minutes
COMPLETED
|
15
|
15
|
|
Period 2: Second Intervention-90 Minutes
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=30 Participants
All participants who were dispensed lenses and successfully completed the study
|
|---|---|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 5.4 • n=30 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Immediately after lens applicationParticipants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.
Outcome measures
| Measure |
Control Lens
n=30 Participants
Participants that received Control lens during either the first or second period of the study.
|
Test Lens
n=30 Participants
Participants that received Test lens during either the first or second period of the study.
|
|---|---|---|
|
Lens Handling at Insertion
|
83 score on a scale
Standard Deviation 16
|
93 score on a scale
Standard Deviation 9
|
Adverse Events
Control Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Lens
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
- Publication restrictions are in place