Trial Outcomes & Findings for Clinical Evaluation of Two Silicone Hydrogel Contact Lenses (NCT NCT05313412)
NCT ID: NCT05313412
Last Updated: 2023-05-09
Results Overview
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
6 hours
Results posted on
2023-05-09
Participant Flow
Thirty-eight participants attended the initial visit with all participants completing the study.
Participant milestones
| Measure |
Lens A, Then Lens B
Participants wore Lens A for 6 hours and then wore Lens B for 6 hours on two separate study days.
|
Lens B, Then Lens A
Participants wore Lens B for 6 hours and then wore Lens A for 6 hours on two separate study days.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
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=38 Participants
Total study population
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=38 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 6 hoursEase of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
Outcome measures
| Measure |
Lens A
n=38 Participants
Participants wore Lens A for six hours.
|
Lens B
n=38 Participants
Participants wore Lens B for six hours.
|
|---|---|---|
|
Ease of Lens Insertion
|
92.1 units on a scale
Standard Deviation 10.3
|
90.9 units on a scale
Standard Deviation 17.4
|
Adverse Events
Lens A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lens B
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