Trial Outcomes & Findings for Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism (NCT NCT02410824)
NCT ID: NCT02410824
Last Updated: 2017-08-21
Results Overview
Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline and 1 Week
Results posted on
2017-08-21
Participant Flow
7 subjects discontinued before lens randomization due to screen failure.
Participant milestones
| Measure |
Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens
Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens.
stenfilcon A: toric contact lens
etafilcon A: toric contact lens
|
Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens
Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens.
etafilcon A: toric contact lens
stenfilcon A: toric contact lens
|
|---|---|---|
|
First Intervention (One Week)
STARTED
|
22
|
23
|
|
First Intervention (One Week)
COMPLETED
|
22
|
22
|
|
First Intervention (One Week)
NOT COMPLETED
|
0
|
1
|
|
Second Intervention (One Week)
STARTED
|
22
|
22
|
|
Second Intervention (One Week)
COMPLETED
|
22
|
22
|
|
Second Intervention (One Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens
Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens.
stenfilcon A: toric contact lens
etafilcon A: toric contact lens
|
Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens
Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens.
etafilcon A: toric contact lens
stenfilcon A: toric contact lens
|
|---|---|---|
|
First Intervention (One Week)
Headache
|
0
|
1
|
Baseline Characteristics
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
Baseline characteristics by cohort
| Measure |
Overall Baseline Characteristics
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair.
|
|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Comfort
Baseline
|
88 units on a scale
Standard Deviation 13
|
78 units on a scale
Standard Deviation 18
|
|
Comfort
1 week
|
85 units on a scale
Standard Deviation 14
|
77 units on a scale
Standard Deviation 21
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Handling
Baseline
|
87 units on a scale
Standard Deviation 12
|
81 units on a scale
Standard Deviation 16
|
|
Handling
1 week
|
87 units on a scale
Standard Deviation 18
|
81 units on a scale
Standard Deviation 23
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Vision
Baseline
|
83 units on a scale
Standard Deviation 16
|
78 units on a scale
Standard Deviation 21
|
|
Vision
1 week
|
86 units on a scale
Standard Deviation 17
|
83 units on a scale
Standard Deviation 17
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekHigh illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
High Visual Acuity
Baseline
|
-0.10 LogMAR
Standard Deviation 0.06
|
-0.08 LogMAR
Standard Deviation 0.06
|
|
High Visual Acuity
1 week
|
-0.09 LogMAR
Standard Deviation 0.07
|
-0.09 LogMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLow illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Low Visual Acuity
Baseline
|
-0.08 LogMAR
Standard Deviation 0.06
|
-0.07 LogMAR
Standard Deviation 0.06
|
|
Low Visual Acuity
1 week
|
-0.07 LogMAR
Standard Deviation 0.07
|
-0.07 LogMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Lens Surface - Wettability
Baseline
|
3.2 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.5
|
|
Lens Surface - Wettability
1 week
|
3.2 units on a scale
Standard Deviation 0.7
|
3.3 units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Lens Surface - Deposits
Baseline
|
0.09 units on a scale
Standard Deviation 0.23
|
0.11 units on a scale
Standard Deviation 0.24
|
|
Lens Surface - Deposits
1 week
|
0.18 units on a scale
Standard Deviation 0.28
|
0.25 units on a scale
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Baseline and 1 weekOcular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Corneal Staining, Type
Baseline - Central
|
0.09 units on a scale
Standard Deviation 0.32
|
0.09 units on a scale
Standard Deviation 0.32
|
|
Corneal Staining, Type
1 week - Central
|
0.07 units on a scale
Standard Deviation 0.27
|
0.02 units on a scale
Standard Deviation 0.21
|
|
Corneal Staining, Type
Baseline - Nasal
|
0.19 units on a scale
Standard Deviation 0.42
|
0.19 units on a scale
Standard Deviation 0.42
|
|
Corneal Staining, Type
1 week - Nasal
|
0.13 units on a scale
Standard Deviation 0.54
|
0.22 units on a scale
Standard Deviation 0.62
|
|
Corneal Staining, Type
Baseline - Temporal
|
0.09 units on a scale
Standard Deviation 0.28
|
0.09 units on a scale
Standard Deviation 0.28
|
|
Corneal Staining, Type
1 week - Temporal
|
0.01 units on a scale
Standard Deviation 0.2
|
0.14 units on a scale
Standard Deviation 0.42
|
|
Corneal Staining, Type
Baseline - Superior
|
0.12 units on a scale
Standard Deviation 0.34
|
0.12 units on a scale
Standard Deviation 0.34
|
|
Corneal Staining, Type
1 week - Superior
|
0.36 units on a scale
Standard Deviation 0.62
|
0.24 units on a scale
Standard Deviation 0.49
|
|
Corneal Staining, Type
Baseline - Inferior
|
0.56 units on a scale
Standard Deviation 0.75
|
0.56 units on a scale
Standard Deviation 0.75
|
|
Corneal Staining, Type
1 week - Inferior
|
0.30 units on a scale
Standard Deviation 0.58
|
0.49 units on a scale
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: Baseline and 1 weekOcular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=\>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Corneal Staining, Extent
Baseline - Central
|
0.07 units on a scale
Standard Deviation 0.30
|
0.07 units on a scale
Standard Deviation 0.30
|
|
Corneal Staining, Extent
1 week - Central
|
0.07 units on a scale
Standard Deviation 0.26
|
0.01 units on a scale
Standard Deviation 0.11
|
|
Corneal Staining, Extent
Baseline - Nasal
|
0.13 units on a scale
Standard Deviation 0.30
|
0.13 units on a scale
Standard Deviation 0.30
|
|
Corneal Staining, Extent
1 week - Nasal
|
0.06 units on a scale
Standard Deviation 0.25
|
0.14 units on a scale
Standard Deviation 0.36
|
|
Corneal Staining, Extent
Baseline - Temporal
|
0.09 units on a scale
Standard Deviation 0.28
|
0.09 units on a scale
Standard Deviation 0.28
|
|
Corneal Staining, Extent
1 week - Temporal
|
0.02 units on a scale
Standard Deviation 0.12
|
0.13 units on a scale
Standard Deviation 0.38
|
|
Corneal Staining, Extent
Baseline - Superior
|
0.09 units on a scale
Standard Deviation 0.27
|
0.09 units on a scale
Standard Deviation 0.27
|
|
Corneal Staining, Extent
1 week - Superior
|
0.22 units on a scale
Standard Deviation 0.46
|
0.20 units on a scale
Standard Deviation 0.42
|
|
Corneal Staining, Extent
Baseline - Inferior
|
0.47 units on a scale
Standard Deviation 0.59
|
0.47 units on a scale
Standard Deviation 0.59
|
|
Corneal Staining, Extent
1 week - Inferior
|
0.28 units on a scale
Standard Deviation 0.55
|
0.41 units on a scale
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: Baseline and 1 weekOcular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Conjunctival Staining
Baseline - Nasal
|
0.36 units on a scale
Standard Deviation 0.60
|
0.36 units on a scale
Standard Deviation 0.60
|
|
Conjunctival Staining
1 week - Nasal
|
1.19 units on a scale
Standard Deviation 0.82
|
1.49 units on a scale
Standard Deviation 0.96
|
|
Conjunctival Staining
Baseline - Temporal
|
0.28 units on a scale
Standard Deviation 0.41
|
0.28 units on a scale
Standard Deviation 0.41
|
|
Conjunctival Staining
1 week - Temporal
|
1.06 units on a scale
Standard Deviation 0.70
|
0.91 units on a scale
Standard Deviation 0.76
|
|
Conjunctival Staining
Baseline - Superior
|
0.09 units on a scale
Standard Deviation 0.30
|
0.09 units on a scale
Standard Deviation 0.30
|
|
Conjunctival Staining
1 week - Superior
|
0.13 units on a scale
Standard Deviation 0.34
|
0.09 units on a scale
Standard Deviation 0.27
|
|
Conjunctival Staining
Baseline - Inferior
|
0.22 units on a scale
Standard Deviation 0.41
|
0.22 units on a scale
Standard Deviation 0.41
|
|
Conjunctival Staining
1 week - Inferior
|
0.68 units on a scale
Standard Deviation 0.79
|
0.78 units on a scale
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: 1 WeekLens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=88 Lenses
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=88 Lenses
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Lens Durability
|
1 Lens tear or nick
|
0 Lens tear or nick
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Lens Fit Acceptance
Baseline
|
3.5 units on a scale
Standard Deviation 0.3
|
3.4 units on a scale
Standard Deviation 0.3
|
|
Lens Fit Acceptance
1 week
|
3.5 units on a scale
Standard Deviation 0.4
|
3.3 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 1 WeekSubjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Dryness
During the Day
|
82 units on a scale
Standard Deviation 18
|
74 units on a scale
Standard Deviation 23
|
|
Dryness
End of Day
|
76 units on a scale
Standard Deviation 21
|
67 units on a scale
Standard Deviation 24
|
SECONDARY outcome
Timeframe: Baseline and 1 weekOverall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
Outcome measures
| Measure |
Stenfilcon A Toric Lens
n=44 Participants
Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
stenfilcon A: toric contact lens
|
Etafilcon A Toric Lens
n=44 Participants
Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.
etafilcon A: toric contact lens
|
|---|---|---|
|
Overall Satisfaction
Baseline
|
87 units on a scale
Standard Deviation 13
|
80 units on a scale
Standard Deviation 16
|
|
Overall Satisfaction
1 week
|
83 units on a scale
Standard Deviation 17
|
77 units on a scale
Standard Deviation 23
|
Adverse Events
Stenfilcon A Toric Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Etafilcon A Toric Lens
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
Restriction type: OTHER