Trial Outcomes & Findings for Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers (NCT NCT05933772)
NCT ID: NCT05933772
Last Updated: 2025-03-11
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
50 participants
Primary outcome timeframe
At the end of one month of wear
Results posted on
2025-03-11
Participant Flow
There were 50 participants enrolled and 1 was discontinued due to lost to follow-up prior to the first lens dispense.
Participant milestones
| Measure |
Lens A, Then Lens B
Participants will wear Lens A for one month and then crossover to Lens B for one month.
Lens A (comfilcon A toric lens): One month wear
Lens B (lehfilcon A toric lens): One month wear
|
Lens B, Then Lens A
Participants will wear Lens B for one month and then crossover to Lens A for one month.
Lens A (comfilcon A toric lens): One month wear
Lens B (lehfilcon A toric lens): One month wear
|
|---|---|---|
|
First Intervention, 1 Month
STARTED
|
25
|
24
|
|
First Intervention, 1 Month
COMPLETED
|
25
|
24
|
|
First Intervention, 1 Month
NOT COMPLETED
|
0
|
0
|
|
Second Intervention, 1 Month
STARTED
|
25
|
24
|
|
Second Intervention, 1 Month
COMPLETED
|
25
|
24
|
|
Second Intervention, 1 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 |
Analysis Population
n=49 Participants
All participants who completed study. (Total Study Population n=49)
|
|---|---|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 5.6 • n=49 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: At the end of one month of wearLens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy).
Outcome measures
| Measure |
Lens A
n=49 Participants
Participants that received Lens A during either the first or second period of the study.
|
Lens B
n=49 Participants
Participants that received Lens B during either the first or second period of the study.
|
|---|---|---|
|
Lens Handling on Removal
|
89 units on a scale
Standard Deviation 17
|
91 units on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: At the end of one month of wearDistance Visual Acuity, using Snellen converted to logMAR.
Outcome measures
| Measure |
Lens A
n=49 Participants
Participants that received Lens A during either the first or second period of the study.
|
Lens B
n=49 Participants
Participants that received Lens B during either the first or second period of the study.
|
|---|---|---|
|
Distance Visual Acuity
|
-0.06 logMAR
Standard Deviation 0.06
|
-0.06 logMAR
Standard Deviation 0.06
|
Adverse Events
Lens A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lens B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lens A
n=49 participants at risk
Participants that received Lens A during either the first or second period of the study.
|
Lens B
n=49 participants at risk
Participants that received Lens B during either the first or second period of the study.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Inflammated skin due to eye make-up spread in eye
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
|
Eye disorders
Red Eye (No Discomfort)
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
|
General disorders
Botox Injection
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
|
Injury, poisoning and procedural complications
Gum Graft Surgery
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
|
General disorders
Insomnolence
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
|
Infections and infestations
Sinus Infection
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
|
General disorders
Stuffy nose and sneezing
|
0.00%
0/49 • Duration of the study, approximately 2 months.
|
2.0%
1/49 • Number of events 1 • Duration of the study, approximately 2 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER