Trial Outcomes & Findings for Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses (NCT NCT05805059)
NCT ID: NCT05805059
Last Updated: 2024-09-26
Results Overview
Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Collected once on day 6 at the end of wear
Results posted on
2024-09-26
Participant Flow
Participant milestones
| Measure |
Control Contact Lens, Then Test Contact Lens
Participants wore Control Lens for 1 week (Period 1), and then Test Lens for 1 week (Period 2).
|
Test Contact Lens, Then Control Contact 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
|
34
|
|
Period 1 (1 Week)
COMPLETED
|
34
|
34
|
|
Period 1 (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (1 Week)
STARTED
|
34
|
34
|
|
Period 2 (1 Week)
COMPLETED
|
34
|
34
|
|
Period 2 (1 Week)
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 |
Analysis Population
n=68 Participants
All participants who completed study. (Total study population n=68)
|
|---|---|
|
Age, Continuous
|
27.0 Years
STANDARD_DEVIATION 4.9 • n=68 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Collected once on day 6 at the end of wearLens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)
Outcome measures
| Measure |
Control Contact Lens
n=68 Participants
Participants that received Control Lens during either the first or second period of the study
|
Test Contact Lens
n=68 Participants
Participants that received Test Lens during either the first or second period of the study
|
|---|---|---|
|
Lens Handling on Removal
|
95 Units on scale
Standard Deviation 12
|
94 Units on scale
Standard Deviation 11
|
Adverse Events
Control Contact Lens
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test Contact 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 Contact Lens
n=68 participants at risk
Participants that received Control Lens during either the first or second period of the study.
|
Test Contact Lens
n=68 participants at risk
Participants that received Test Lens during either the first or second period of the study.
|
|---|---|---|
|
Eye disorders
eye twitching
|
1.5%
1/68 • Number of events 1 • Duration of the study, approximately 2 weeks.
\[Not Specified\]
|
0.00%
0/68 • Duration of the study, approximately 2 weeks.
\[Not Specified\]
|
|
Eye disorders
Hyperemia
|
0.00%
0/68 • Duration of the study, approximately 2 weeks.
\[Not Specified\]
|
1.5%
1/68 • Number of events 2 • Duration of the study, approximately 2 weeks.
\[Not Specified\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place