Trial Outcomes & Findings for Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere (NCT NCT06817785)
NCT ID: NCT06817785
Last Updated: 2026-08-31
Results Overview
The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).
COMPLETED
NA
45 participants
Immediately after lens application
2026-08-31
Participant Flow
Forty Five participants were screened. All the participants who were eligible in the study were included in the analysis. (n=45)
Participant milestones
| Measure |
Lens 2 (Somofilcon A)
All participants wore lens 2 for 15 minutes (Period 2).
Lens 2 (somofilcon A): 15 minutes of daily wear
|
Lens 1 (Ocufilcon D)
All participants wore lens 1 for 15 minutes (Period 1).
Lens 1 (ocufilcon D): 15 minutes of daily wear
|
|---|---|---|
|
Lens 1 (15 minutes)
STARTED
|
0
|
45
|
|
Lens 1 (15 minutes)
COMPLETED
|
0
|
45
|
|
Lens 1 (15 minutes)
NOT COMPLETED
|
0
|
0
|
|
Lens 2 (15 minutes)
STARTED
|
45
|
0
|
|
Lens 2 (15 minutes)
COMPLETED
|
45
|
0
|
|
Lens 2 (15 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 |
All Study Participant
n=45 Participants
Includes all study participants
|
|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 10.8 • n=45 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Immediately after lens applicationPopulation: Overall number of participants analyzed
The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).
Outcome measures
| Measure |
Lens 1 (Ocufilcon D)
n=45 Participants
All participants wore lens 1 for 15 minutes (Period 1).
Lens 1 (ocufilcon D): 15 minutes of daily wear
|
Lens 2 (Somofilcon A)
n=45 Participants
All participants wore lens 2 for 15 minutes (Period 2).
Lens 2 (somofilcon A): 15 minutes of daily wear
|
|---|---|---|
|
Lens Comfort
|
88 Units on scale
Standard Deviation 14
|
93 Units on scale
Standard Deviation 8
|
Adverse Events
Lens 1 (Ocufilcon D)
Lens 2 (Somofilcon A)
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