Trial Outcomes & Findings for Clinical Evaluation of Two Toric Soft Contact Lenses (NCT NCT06490302)
NCT ID: NCT06490302
Last Updated: 2025-08-22
Results Overview
Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
At the end of 15 minutes of daily wear
Results posted on
2025-08-22
Participant Flow
Forty participants were screened. All the participants who were eligible in the study were included in the analysis. (n=40)
Participant milestones
| Measure |
Lens A (Ocufilcon D)
All participants wore lens A for 15 minutes (Period 1).
Lens A (ocufilcon D): 15 minutes of daily wear
|
Lens B (Fanfilcon A)
All participants wore lens B for 15 minutes (Period 2).
Lens B (fanfilcon A): 15 minutes of daily wear
|
|---|---|---|
|
Period 1: Lens A (15 Minutes)
STARTED
|
40
|
0
|
|
Period 1: Lens A (15 Minutes)
COMPLETED
|
40
|
0
|
|
Period 1: Lens A (15 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Period 2: Lens B (15 Minutes)
STARTED
|
0
|
40
|
|
Period 2: Lens B (15 Minutes)
COMPLETED
|
0
|
40
|
|
Period 2: Lens B (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 Participants
n=40 Participants
Includes all Study Participants
|
|---|---|
|
Age, Continuous
|
25.6 years
STANDARD_DEVIATION 7.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: At the end of 15 minutes of daily wearOverall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)
Outcome measures
| Measure |
Lens A (Ocufilcon D)
n=40 Participants
All participants wore lens A for 15 minutes (Period 1).
Lens A (ocufilcon D): 15 minutes of daily wear
|
Lens B (Fanfilcon A)
n=40 Participants
All participants wore lens B for 15 minutes (Period 2).
Lens B (fanfilcon A): 15 minutes of daily wear
|
|---|---|---|
|
Overall Fit Acceptance
|
3.6 units on a scale
Standard Deviation 0.8
|
3.7 units on a scale
Standard Deviation 0.6
|
Adverse Events
Lens A (Ocufilcon D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lens B (Fanfilcon A)
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