Trial Outcomes & Findings for Performance of Toric Silicone Hydrogel Contact Lenses (NCT NCT05097144)
NCT ID: NCT05097144
Last Updated: 2023-10-17
Results Overview
Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
1 month
Results posted on
2023-10-17
Participant Flow
This study was conducted at a single investigative site located in Mexico City, Mexico.
Participant milestones
| Measure |
Lens A, Then Lens B
Participants first wore Lens A for one month and then wore Lens B for one month.
|
Lens B, Then Lens A
Participants first wore Lens B for one month and then wore Lens A for one month.
|
|---|---|---|
|
Period 1 (One Month)
STARTED
|
18
|
18
|
|
Period 1 (One Month)
COMPLETED
|
18
|
18
|
|
Period 1 (One Month)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (One Month)
STARTED
|
18
|
18
|
|
Period 2 (One Month)
COMPLETED
|
18
|
18
|
|
Period 2 (One Month)
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 |
All Study Participants
n=36 Participants
Includes all study participants.
|
|---|---|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 6.8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All participants who were exposed to study lenses and completed each study visit.
Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.
Outcome measures
| Measure |
Lens A
n=36 Participants
Participants that received Lens A during either the first or second period of the study.
|
Lens B
n=36 Participants
Participants that received Lens B during either the first or second period of the study.
|
|---|---|---|
|
Lens Handling (Insertion and Removal)
|
9.47 units on a scale
Standard Deviation 1.00
|
8.33 units on a scale
Standard Deviation 1.54
|
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