Trial Outcomes & Findings for The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses (NCT NCT02643004)
NCT ID: NCT02643004
Last Updated: 2017-08-23
Results Overview
Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
COMPLETED
NA
70 participants
Baseline and 1 week
2017-08-23
Participant Flow
Participant milestones
| Measure |
Senofilcon A, Then Stenfilcon A
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
Stenfilcon A: contact lens
|
Stenfilcon A, Then Senofilcon A
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
Senofilcon A: contact lens
|
|---|---|---|
|
First Intervention (One Week)
STARTED
|
35
|
35
|
|
First Intervention (One Week)
COMPLETED
|
35
|
35
|
|
First Intervention (One Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (One Week)
STARTED
|
35
|
35
|
|
Second Intervention (One Week)
COMPLETED
|
35
|
35
|
|
Second Intervention (One Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Baseline Characteristics
n=70 Participants
Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
Stenfilcon A: contact lens
|
|---|---|
|
Age, Continuous
|
30.6 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.
Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Ocular Physiology
Baseline - Corneal staining
|
0.13 units on a scale
Standard Deviation 0.30
|
0.13 units on a scale
Standard Deviation 0.30
|
|
Ocular Physiology
1 week - Corneal staining
|
0.21 units on a scale
Standard Deviation 0.34
|
0.15 units on a scale
Standard Deviation 0.29
|
|
Ocular Physiology
Baseline - Conjunctival staining
|
0.21 units on a scale
Standard Deviation 0.30
|
0.21 units on a scale
Standard Deviation 0.30
|
|
Ocular Physiology
1 week - Conjunctival staining
|
0.82 units on a scale
Standard Deviation 0.51
|
0.48 units on a scale
Standard Deviation 0.43
|
|
Ocular Physiology
Baseline - Conjunctival hyperaemia
|
0.81 units on a scale
Standard Deviation 0.23
|
0.81 units on a scale
Standard Deviation 0.23
|
|
Ocular Physiology
1 week - Conjunctival hyperaemia
|
0.82 units on a scale
Standard Deviation 0.25
|
0.86 units on a scale
Standard Deviation 0.24
|
|
Ocular Physiology
Baseline - Limbal hyperaemia
|
0.70 units on a scale
Standard Deviation 0.28
|
0.70 units on a scale
Standard Deviation 0.28
|
|
Ocular Physiology
1 week - Limbal hyperaemia
|
0.69 units on a scale
Standard Deviation 0.26
|
0.75 units on a scale
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Overall Subjective Score of Lenses
Baseline
|
92.3 units on a scale
Standard Deviation 8.8
|
89.4 units on a scale
Standard Deviation 11.1
|
|
Overall Subjective Score of Lenses
1 week
|
87.0 units on a scale
Standard Deviation 13.1
|
80.0 units on a scale
Standard Deviation 18.3
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Comfort
Baseline
|
90.8 units on a scale
Standard Deviation 10.2
|
90.5 units on a scale
Standard Deviation 10.7
|
|
Comfort
1 week
|
87.0 units on a scale
Standard Deviation 11.5
|
82.1 units on a scale
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: 1 weekPopulation: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Dryness
|
82.3 units on a scale
Standard Deviation 14.3
|
77.7 units on a scale
Standard Deviation 17.8
|
PRIMARY outcome
Timeframe: Baseline and 1 weekPopulation: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.
Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Vision
Baseline
|
94.7 units on a scale
Standard Deviation 6.8
|
91.9 units on a scale
Standard Deviation 9.5
|
|
Vision
1 week
|
93.4 units on a scale
Standard Deviation 7.9
|
88.4 units on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: BaselineLens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Horizontal Centration
Extremely nasal
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Horizontal Centration
Slightly nasal
|
3 percentage of subjects
|
6 percentage of subjects
|
|
Horizontal Centration
Optimum
|
61 percentage of subjects
|
73 percentage of subjects
|
|
Horizontal Centration
Slightly temporal
|
36 percentage of subjects
|
21 percentage of subjects
|
|
Horizontal Centration
Extremely temporal
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Outcome measures
| Measure |
Senofilcon A
n=69 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Horizontal Centration
Extremely nasal
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Horizontal Centration
Slightly nasal
|
1.4 percentage of subjects
|
7.0 percentage of subjects
|
|
Horizontal Centration
Optimum
|
72.5 percentage of subjects
|
70.0 percentage of subjects
|
|
Horizontal Centration
Slightly temporal
|
26.1 percentage of subjects
|
23.0 percentage of subjects
|
|
Horizontal Centration
Extremely temporal
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: BaselineLens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Vertical Centration
Extremely nasal
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Vertical Centration
Slightly nasal
|
17.0 percentage of subjects
|
15.7 percentage of subjects
|
|
Vertical Centration
Optimum
|
64.0 percentage of subjects
|
65.7 percentage of subjects
|
|
Vertical Centration
Slightly temporal
|
19.0 percentage of subjects
|
18.6 percentage of subjects
|
|
Vertical Centration
Extremely temporal
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Outcome measures
| Measure |
Senofilcon A
n=69 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Vertical Centration
Extremely nasal
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Vertical Centration
Slightly nasal
|
20.3 percentage of subjects
|
23.0 percentage of subjects
|
|
Vertical Centration
Optimum
|
65.2 percentage of subjects
|
65.0 percentage of subjects
|
|
Vertical Centration
Slightly temporal
|
14.5 percentage of subjects
|
12.0 percentage of subjects
|
|
Vertical Centration
Extremely temporal
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: BaselineLens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Movement
Extremely inadequate
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Lens Movement
Slightly inadequate
|
29 percentage of subjects
|
3 percentage of subjects
|
|
Lens Movement
Optimum
|
67 percentage of subjects
|
64 percentage of subjects
|
|
Lens Movement
Slightly excessive
|
4 percentage of subjects
|
33 percentage of subjects
|
|
Lens Movement
Extremely excessive
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 1 WeekPopulation: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Outcome measures
| Measure |
Senofilcon A
n=69 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Movement
Extremely inadequate
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Lens Movement
Slightly inadequate
|
42 percentage of subjects
|
7 percentage of subjects
|
|
Lens Movement
Optimum
|
57 percentage of subjects
|
65 percentage of subjects
|
|
Lens Movement
Slightly excessive
|
1 percentage of subjects
|
28 percentage of subjects
|
|
Lens Movement
Extremely excessive
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: Protocol deviations occurred and therefore resulted in incomplete data sets.
Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Visual Acuity
Baseline: High Contrast
|
-0.14 LogMAR
Standard Deviation 0.07
|
-0.11 LogMAR
Standard Deviation 0.08
|
|
Visual Acuity
Baseline: Low Contrast
|
0.12 LogMAR
Standard Deviation 0.10
|
0.16 LogMAR
Standard Deviation 0.10
|
|
Visual Acuity
1 week: High Contrast
|
-0.13 LogMAR
Standard Deviation 0.07
|
-0.10 LogMAR
Standard Deviation 0.09
|
|
Visual Acuity
1 week: Low Contrast
|
0.13 LogMAR
Standard Deviation 0.09
|
0.17 LogMAR
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: BaselineLens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Surface - Deposition
Normal
|
94 percentage of subjects
|
97 percentage of subjects
|
|
Lens Surface - Deposition
Trace
|
6 percentage of subjects
|
3 percentage of subjects
|
|
Lens Surface - Deposition
Mild
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Lens Surface - Deposition
Moderate
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Lens Surface - Deposition
Severe
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 1 weekPopulation: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Senofilcon A
n=69 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Surface - Deposition
Normal
|
91.3 percentage of subjects
|
99.0 percentage of subjects
|
|
Lens Surface - Deposition
Trace
|
7.2 percentage of subjects
|
1.0 percentage of subjects
|
|
Lens Surface - Deposition
Mild
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Deposition
Moderate
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Deposition
Severe
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: BaselineLens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Surface - Debris
Normal
|
82.9 percentage of subjects
|
93.0 percentage of subjects
|
|
Lens Surface - Debris
Trace
|
14.3 percentage of subjects
|
7.0 percentage of subjects
|
|
Lens Surface - Debris
Mild
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Debris
Moderate
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Debris
Severe
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: 1 weekPopulation: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Senofilcon A
n=69 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Surface - Debris
Normal
|
84.1 percentage of subjects
|
96.0 percentage of subjects
|
|
Lens Surface - Debris
Trace
|
14.5 percentage of subjects
|
4.0 percentage of subjects
|
|
Lens Surface - Debris
Mild
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Debris
Moderate
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Debris
Severe
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: BaselineLens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Senofilcon A
n=70 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=70 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Surface - Wettability
Normal
|
79 percentage of subjects
|
86 percentage of subjects
|
|
Lens Surface - Wettability
Trace
|
20 percentage of subjects
|
11 percentage of subjects
|
|
Lens Surface - Wettability
Mild
|
1 percentage of subjects
|
3 percentage of subjects
|
|
Lens Surface - Wettability
Moderate
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Lens Surface - Wettability
Severe
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 1 weekPopulation: A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.
Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Senofilcon A
n=69 Participants
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Senofilcon A: contact lens
|
Stenfilcon A
n=69 Participants
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
Stenfilcon A: contact lens
|
|---|---|---|
|
Lens Surface - Wettability
Normal
|
81.2 percentage of subjects
|
71.0 percentage of subjects
|
|
Lens Surface - Wettability
Trace
|
15.9 percentage of subjects
|
25.0 percentage of subjects
|
|
Lens Surface - Wettability
Mild
|
1.4 percentage of subjects
|
4.0 percentage of subjects
|
|
Lens Surface - Wettability
Moderate
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Lens Surface - Wettability
Severe
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
Adverse Events
Senofilcon A
Stenfilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Manager Global Medical Scientific Affairs
CooperVision Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER