Trial Outcomes & Findings for Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses (NCT NCT02921412)
NCT ID: NCT02921412
Last Updated: 2018-04-10
Results Overview
High contrast distance visual acuity is measured by LogMAR.
COMPLETED
NA
37 participants
baseline, 2 weeks, 1 month
2018-04-10
Participant Flow
37 participants were initially enrolled (assigned a study ID), with 1 failing the screening. A total of 36 participants wore the control lens (enfilcon A toric) first and then refitted and dispensed the test lenses (fanfilcon A toric) at baseline visit. There were no discontinuations.
Participant milestones
| Measure |
All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
All participants wore enfilcon A toric lens (habitual) and then wore fanfilcon A toric lenses for 1 month.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enfilcon A Toric / Fanfilcon A Toric
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 6.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 1 monthPopulation: Analysis was performed prior to one participant completing the 2 week and 1 month visits.
High contrast distance visual acuity is measured by LogMAR.
Outcome measures
| Measure |
Fanfilcon A Toric (2 Weeks)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (1 Month)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Enfilcon A Toric (Baseline)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (Dispense)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
|---|---|---|---|---|
|
Visual Acuity
|
-0.05 logMAR
Standard Deviation 0.05
|
-0.04 logMAR
Standard Deviation 0.04
|
-0.05 logMAR
Standard Deviation 0.05
|
-0.05 logMAR
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 1 monthPopulation: Analysis was performed prior to one participant completing the 2 week and 1 month visits.
Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Outcome measures
| Measure |
Fanfilcon A Toric (2 Weeks)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (1 Month)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Enfilcon A Toric (Baseline)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (Dispense)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
|---|---|---|---|---|
|
Centration
Optimum
|
30 Participants
|
33 Participants
|
34 Participants
|
35 Participants
|
|
Centration
Acceptable
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Centration
Unacceptable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 1 monthPopulation: Analysis was performed prior to one participant completing the 2 week and 1 month visits.
Corneal coverage will be assessed (yes/no)
Outcome measures
| Measure |
Fanfilcon A Toric (2 Weeks)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (1 Month)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Enfilcon A Toric (Baseline)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (Dispense)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
|---|---|---|---|---|
|
Corneal Coverage
Yes
|
35 Participants
|
35 Participants
|
36 Participants
|
36 Participants
|
|
Corneal Coverage
No
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 1 monthPopulation: Analysis was performed prior to one participant completing the 2 week and 1 month visits.
Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)
Outcome measures
| Measure |
Fanfilcon A Toric (2 Weeks)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (1 Month)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Enfilcon A Toric (Baseline)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (Dispense)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
|---|---|---|---|---|
|
Post-blink Movement
|
1.69 units on a scale
Standard Deviation 0.47
|
1.86 units on a scale
Standard Deviation 0.49
|
1.83 units on a scale
Standard Deviation 0.51
|
1.92 units on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: baseline, 2 weeks, 1 monthPopulation: Analysis was performed prior to one participant completing the 2 week and 1 month visits.
Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Outcome measures
| Measure |
Fanfilcon A Toric (2 Weeks)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (1 Month)
n=35 Participants
All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Enfilcon A Toric (Baseline)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
Fanfilcon A Toric (Dispense)
n=36 Participants
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
|
|---|---|---|---|---|
|
Fit Acceptability
|
3.1 units on a scale
Standard Deviation 0.8
|
3.1 units on a scale
Standard Deviation 0.6
|
3.3 units on a scale
Standard Deviation 0.6
|
3.3 units on a scale
Standard Deviation 0.5
|
Adverse Events
All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
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 Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
- Publication restrictions are in place
Restriction type: OTHER