Trial Outcomes & Findings for A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses (NCT NCT03684928)
NCT ID: NCT03684928
Last Updated: 2020-06-26
Results Overview
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline
Results posted on
2020-06-26
Participant Flow
Participant milestones
| Measure |
Comfilcon A (Test) Then Senofilcon A (Control)
Participants were randomized to wear comfilcon A contact lenses first then or senofilcon C contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
Senofilcon C: Daily wear contact lenses
|
Senofilcon C (Control) Then Comfilcon A (Test)
Participants were randomized to wear Senofilcon C control contact lenses first then Comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
First Intervention
STARTED
|
23
|
22
|
|
First Intervention
COMPLETED
|
23
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
3
|
|
Second Intervention
STARTED
|
21
|
19
|
|
Second Intervention
COMPLETED
|
20
|
19
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Comfilcon A (Test) Then Senofilcon A (Control)
Participants were randomized to wear comfilcon A contact lenses first then or senofilcon C contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
Senofilcon C: Daily wear contact lenses
|
Senofilcon C (Control) Then Comfilcon A (Test)
Participants were randomized to wear Senofilcon C control contact lenses first then Comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
0
|
1
|
|
First Intervention
Withdrawal by Subject
|
0
|
2
|
|
Second Intervention
Soft Tissue Injury
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study
n=45 Participants
Total Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=45 Participants
|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 8.9 • n=45 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=45 Participants
|
|
Region of Enrollment
Canada
|
45 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: BaselineSubjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Outcome measures
| Measure |
Comfilcon A (Test)
n=39 Participants
Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
|
Senofilcon C (Control)
n=39 Participants
Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
Ease of Insertion(Handling)
|
9.1 units on a scale
Standard Deviation 1.2
|
9.2 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 2 weeksSubjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Outcome measures
| Measure |
Comfilcon A (Test)
n=39 Participants
Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
|
Senofilcon C (Control)
n=39 Participants
Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
Ease of Insertion (Handling)
|
8.9 units on a scale
Standard Deviation 1.1
|
8.5 units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 1 monthSubjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Outcome measures
| Measure |
Comfilcon A (Test)
n=39 Participants
Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
|
Senofilcon C (Control)
n=39 Participants
Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
Ease of Insertion(Handling)
|
8.8 units on a scale
Standard Deviation 1.3
|
8.5 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: BaselineLens relocation after 10 blinks, after 30º rotation mislocation
Outcome measures
| Measure |
Comfilcon A (Test)
n=39 Participants
Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
|
Senofilcon C (Control)
n=39 Participants
Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
Rotational Recovery After Lens Mislocation
Nasal
|
27 Degrees
Standard Deviation 4
|
23 Degrees
Standard Deviation 6
|
|
Rotational Recovery After Lens Mislocation
Temporal
|
23 Degrees
Standard Deviation 8
|
19 Degrees
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 1 monthLens relocation after 10 blinks, after 30º rotation mislocation.
Outcome measures
| Measure |
Comfilcon A (Test)
n=39 Participants
Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test): Daily wear contact lenses
|
Senofilcon C (Control)
n=39 Participants
Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study.
Senofilcon C: Daily wear contact lenses
|
|---|---|---|
|
Rotational Recovery After Lens Mislocation
Nasal
|
26 Degrees
Standard Deviation 6
|
23 Degrees
Standard Deviation 6
|
|
Rotational Recovery After Lens Mislocation
Temporal
|
23 Degrees
Standard Deviation 7
|
18 Degrees
Standard Deviation 5
|
Adverse Events
Comfilcon A (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Senofilcon C (Control)
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