Trial Outcomes & Findings for A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses (NCT NCT06438601)
NCT ID: NCT06438601
Last Updated: 2025-08-11
Results Overview
Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
At the end of 15 minutes of daily wear
Results posted on
2025-08-11
Participant Flow
Forty participants were screened. Of those, four participants were ineligible and excluded from the study. Thirty-six participants were enrolled.
Participant milestones
| Measure |
Lens A (Omafilcon A)
All participants wore Lens A for 15 minutes (Period 1).
Lens A (omafilcon A): 15 minutes of daily wear.
|
Lens B (Comfilcon A)
All participants wore Lens B for 15 minutes (Period 2).
Lens B (comfilcon A): 15 minutes of daily wear.
|
|---|---|---|
|
Period 1: Lens A (15 Minutes)
STARTED
|
36
|
0
|
|
Period 1: Lens A (15 Minutes)
COMPLETED
|
34
|
0
|
|
Period 1: Lens A (15 Minutes)
NOT COMPLETED
|
2
|
0
|
|
Period 2: Lens B (15 Minutes)
STARTED
|
0
|
34
|
|
Period 2: Lens B (15 Minutes)
COMPLETED
|
0
|
34
|
|
Period 2: Lens B (15 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lens A (Omafilcon A)
All participants wore Lens A for 15 minutes (Period 1).
Lens A (omafilcon A): 15 minutes of daily wear.
|
Lens B (Comfilcon A)
All participants wore Lens B for 15 minutes (Period 2).
Lens B (comfilcon A): 15 minutes of daily wear.
|
|---|---|---|
|
Period 1: Lens A (15 Minutes)
Withdrawal by Subject
|
1
|
0
|
|
Period 1: Lens A (15 Minutes)
Use of eye drops between study visits
|
1
|
0
|
Baseline Characteristics
Four participants were ineligible, of which two were ineligible due to astigmatism in their left eye, one had poor visual acuity in their right eye and one did not require a reading add.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=36 Participants
Includes all enrolled participants
|
|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 8.3 • n=36 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=36 Participants • Four participants were ineligible, of which two were ineligible due to astigmatism in their left eye, one had poor visual acuity in their right eye and one did not require a reading add.
|
|
Sex: Female, Male
Male
|
13 Participants
n=36 Participants • Four participants were ineligible, of which two were ineligible due to astigmatism in their left eye, one had poor visual acuity in their right eye and one did not require a reading add.
|
PRIMARY outcome
Timeframe: At the end of 15 minutes of daily wearPopulation: All participants that completed the study.
Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).
Outcome measures
| Measure |
Lens A (Omafilcon A)
n=34 Participants
All participants wore Lens A for 15 minutes (Period 1).
Lens A (omafilcon A): 15 minutes of daily wear.
|
Lens B (Comfilcon A)
n=34 Participants
All participants wore Lens B for 15 minutes (Period 2).
Lens B (comfilcon A): 15 minutes of daily wear.
|
|---|---|---|
|
Subjective Distance Vision
|
77.1 units on a scale
Standard Deviation 19.6
|
80.0 units on a scale
Standard Deviation 14.5
|
Adverse Events
Lens A (Omafilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lens B (Comfilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lens A (Omafilcon A)
n=36 participants at risk
Participants that received Lens A
|
Lens B (Comfilcon A)
n=34 participants at risk
Participants that received Lens B
|
No Intervention
n=36 participants at risk
All Study Participants
|
|---|---|---|---|
|
Eye disorders
Suspect vitreous detachment
|
0.00%
0/36 • Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
|
0.00%
0/34 • Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
|
2.8%
1/36 • Number of events 1 • Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
|
|
Eye disorders
Sub-conjunctival haemorrhage
|
0.00%
0/36 • Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
|
0.00%
0/34 • Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
|
2.8%
1/36 • Number of events 1 • Through study completion, approximately sixteen weeks.
The Adverse Events cannot be attributed to one intervention or the other. Therefore, an additional Arm/Group was added to report these Adverse Events (i.e., a total of 3 Arms/Groups).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place