Trial Outcomes & Findings for Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently (NCT NCT05805150)
NCT ID: NCT05805150
Last Updated: 2024-06-25
Results Overview
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Collected once on day 6 at the end of wear
Results posted on
2024-06-25
Participant Flow
Participant milestones
| Measure |
Control Lens, Then Test Lens
Participants wore Control Lens for 1 week (Period 1), and then Test Lens for 1 week (Period 2).
|
Test Lens, Then Control Lens
Participants wore Test Lens for 1 week (Period 1), and then Control Lens for 1 week (Period 2).
|
|---|---|---|
|
Period 1 (1 Week)
STARTED
|
34
|
35
|
|
Period 1 (1 Week)
COMPLETED
|
34
|
35
|
|
Period 1 (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (1 Week)
STARTED
|
34
|
35
|
|
Period 2 (1 Week)
COMPLETED
|
34
|
34
|
|
Period 2 (1 Week)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control Lens, Then Test Lens
Participants wore Control Lens for 1 week (Period 1), and then Test Lens for 1 week (Period 2).
|
Test Lens, Then Control Lens
Participants wore Test Lens for 1 week (Period 1), and then Control Lens for 1 week (Period 2).
|
|---|---|---|
|
Period 2 (1 Week)
Should not have been enrolled. Participant was nursing (lactating).
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Analysis Population
n=68 Participants
All participants who completed study. (Total study population n=68)
|
|---|---|
|
Age, Continuous
|
27.7 Years
STANDARD_DEVIATION 5.6 • n=68 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Collected once on day 6 at the end of wearPopulation: Total Analysis Population is 68, only those who completed the study.
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)
Outcome measures
| Measure |
Control Lens
n=68 Participants
Participants that received Control lens during either the first or second period of the study
|
Test Lens
n=68 Participants
Participants that received Test lens during either the first or second period of the study
|
|---|---|---|
|
Lens Handling on Removal
|
90 Units on a scale
Standard Deviation 18
|
95 Units on a scale
Standard Deviation 8
|
Adverse Events
Control Lens
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test Lens
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Lens
n=69 participants at risk
Participants that received Control lens during either the first or second period of the study
|
Test Lens
n=69 participants at risk
Participants that received Test lens during either the first or second period of the study
|
|---|---|---|
|
Eye disorders
Redness and Swelling
|
0.00%
0/69 • Duration of the study, approximately 2 weeks.
|
1.4%
1/69 • Number of events 1 • Duration of the study, approximately 2 weeks.
|
|
Eye disorders
Redness and small bump on lid
|
1.4%
1/69 • Number of events 1 • Duration of the study, approximately 2 weeks.
|
0.00%
0/69 • Duration of the study, approximately 2 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place