Trial Outcomes & Findings for The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses (NCT NCT02920970)
NCT ID: NCT02920970
Last Updated: 2019-01-16
Results Overview
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
COMPLETED
NA
72 participants
1 week
2019-01-16
Participant Flow
There were 72 participants were enrolled in the study, of which 70 were dispensed a contact lens to wear and 2 failed screening.
Participant milestones
| Measure |
Stenfilcon A First Then Narafilcon A
Participants are randomized to wear stenfilcon A lens first for one week then narafilcon A.
|
Narafilcon A First Then Stenfilcon A
Participants are randomized to wear narafilcon A lens first for one week then stenfilcon A.
|
|---|---|---|
|
First Intervention
STARTED
|
38
|
32
|
|
First Intervention
COMPLETED
|
38
|
30
|
|
First Intervention
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
38
|
30
|
|
Second Intervention
COMPLETED
|
37
|
30
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Stenfilcon A First Then Narafilcon A
Participants are randomized to wear stenfilcon A lens first for one week then narafilcon A.
|
Narafilcon A First Then Stenfilcon A
Participants are randomized to wear narafilcon A lens first for one week then stenfilcon A.
|
|---|---|---|
|
First Intervention
Protocol Violation
|
0
|
1
|
|
First Intervention
Adverse Event
|
0
|
1
|
|
Second Intervention
Poor Lens Fit
|
1
|
0
|
Baseline Characteristics
The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Number of Baseline Participants
n=72 Participants
Total number of participants enrolled in the study.
|
|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Ocular Physiology
Conjuctival hyperaemia
|
0.84 units on a scale
Standard Deviation 0.25
|
0.76 units on a scale
Standard Deviation 0.27
|
|
Ocular Physiology
Limbal hyperaemia
|
0.75 units on a scale
Standard Deviation 0.28
|
0.62 units on a scale
Standard Deviation 0.31
|
|
Ocular Physiology
Corneal vascularisation
|
0.05 units on a scale
Standard Deviation 0.14
|
0.03 units on a scale
Standard Deviation 0.09
|
|
Ocular Physiology
Microcysts
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Ocular Physiology
Oedema
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Ocular Physiology
Corneal staining
|
0.31 units on a scale
Standard Deviation 0.41
|
0.33 units on a scale
Standard Deviation 0.40
|
|
Ocular Physiology
Conjuctival staining
|
0.57 units on a scale
Standard Deviation 0.49
|
0.76 units on a scale
Standard Deviation 0.64
|
|
Ocular Physiology
Papillary conjuctivitis
|
1.01 units on a scale
Standard Deviation 0.35
|
1.00 units on a scale
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at follow up due to protocol deviations.
Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Visual Acuity
High Contrast
|
-0.12 LogMAR
Standard Deviation 0.07
|
-0.10 LogMAR
Standard Deviation 0.08
|
|
Visual Acuity
Low Contrast
|
0.17 LogMAR
Standard Deviation 0.09
|
0.17 LogMAR
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Subjective responses for overall 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 |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Comfort Level of Stenfilcon A and Narafilcon A Lenses
|
91.4 units on a scale
Standard Deviation 9.8
|
83.1 units on a scale
Standard Deviation 14.8
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations
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 |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Dryness of Stenfilcon A and Narafilcon A Lenses
|
82.1 units on a scale
Standard Deviation 17.2
|
81.2 units on a scale
Standard Deviation 16.7
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
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 |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Vision of Stenfilcon A and Narafilcon A Lenses
|
91.4 units on a scale
Standard Deviation 9.4
|
88.4 units on a scale
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Grade 0
|
64 Participants
|
62 Participants
|
|
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Grade 1
|
4 Participants
|
5 Participants
|
|
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Grade 2
|
0 Participants
|
1 Participants
|
|
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Grade 3
|
0 Participants
|
0 Participants
|
|
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Grade 0
|
55 Participants
|
59 Participants
|
|
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Grade 1
|
8 Participants
|
5 Participants
|
|
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Grade 2
|
4 Participants
|
4 Participants
|
|
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Grade 3
|
1 Participants
|
0 Participants
|
|
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Extremely Nasal
|
0 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Slightly Nasal
|
0 Participants
|
0 Participants
|
|
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Optimum
|
44 Participants
|
46 Participants
|
|
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Slightly Temporal
|
24 Participants
|
22 Participants
|
|
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Extremely Temporal
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Extremely inferior
|
0 Participants
|
0 Participants
|
|
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Slightly inferior
|
11 Participants
|
12 Participants
|
|
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Optimum
|
42 Participants
|
48 Participants
|
|
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Slightly superior
|
15 Participants
|
8 Participants
|
|
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Extremely superior
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Extremely inadequate
|
0 Participants
|
0 Participants
|
|
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Slightly inadequate
|
4 Participants
|
2 Participants
|
|
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Optimum
|
56 Participants
|
60 Participants
|
|
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Slighlty excessive
|
8 Participants
|
6 Participants
|
|
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Extremely excessive
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Outcome measures
| Measure |
Stenfilcon A
n=68 Participants
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
|
Narafilcon A
n=65 Participants
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
|
|---|---|---|
|
Lens Movement
Extremely inadequate
|
0 Participants
|
0 Participants
|
|
Lens Movement
Slightly inadequate
|
3 Participants
|
5 Participants
|
|
Lens Movement
Optimum
|
55 Participants
|
54 Participants
|
|
Lens Movement
Slightly excessive
|
10 Participants
|
9 Participants
|
|
Lens Movement
Extremely excessive
|
0 Participants
|
0 Participants
|
Adverse Events
Stenfilcon A
Narafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stenfilcon A
n=70 participants at risk
Participants are randomized to wear stenfilcon A as the first or second lens pair for one week during the cross over study.
|
Narafilcon A
n=70 participants at risk
Participants are randomized to wear narafilcon A as the first or second lens pair for one week during the cross over study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Non-ocular Non-Significant
|
2.9%
2/70 • Number of events 2 • 1 week
Adverse events were collected during the study visit exams.
|
8.6%
6/70 • Number of events 6 • 1 week
Adverse events were collected during the study visit exams.
|
Additional Information
Sr. Manager Global Medical Scientific Affairs
CooperVision Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place